6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-002627-16-ES (EUCTR) | 31/03/2022 | 31/03/2022 | A study for evaluation of the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pirepemat, 50 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate Product Name: Pirepemat, 100 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate | Integrative Research Laboratories Sweden AB (IRLAB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | France;Poland;Spain;Germany;Sweden | ||
| 2 | EUCTR2019-002627-16-PL (EUCTR) | 21/02/2022 | 11/01/2022 | A study for evaluation of the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pirepemat, 50 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate Product Name: Pirepemat, 100 mg Product Code: IRL752 INN or Proposed INN: Pirepemat Other descriptive name: Pirepemat x fumarate | Integrative Research Laboratories Sweden AB (IRLAB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | France;Spain;Poland;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2020-002754-24-DE (EUCTR) | 19/01/2022 | 14/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 4 | NCT05523791 (ClinicalTrials.gov) | January 1, 2022 | 17/8/2022 | Whey Protein Supplementation in Patients With Parkinson's Disease | Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response? | Parkinson Disease | Dietary Supplement: Fortiral;Dietary Supplement: Mg++ | Ospedale Generale Di Zona Moriggia-Pelascini | NULL | Completed | 60 Years | N/A | All | 51 | N/A | Italy |
| 5 | NCT04990284 (ClinicalTrials.gov) | November 29, 2021 | 27/7/2021 | eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. | A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Opicapone;Drug: L-DOPA/DDCI | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 100 | Phase 4 | Germany;Italy;Portugal;Spain;United Kingdom |
| 6 | EUCTR2020-002754-24-IT (EUCTR) | 09/09/2021 | 30/08/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg tablets Product Name: SINEMET 100 mg + 25 mg compresse Product Code: [023145028] INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: Carbidopa Trade Name: Madopar 125 mg T, tablets Product Name: Madopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride) Product Code: [6036937.00.01] INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: Levodopa Other descriptive name: Levodopa Trade Name: Ongentys 50 mg hard capsules Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone Other descriptive name: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 7 | NCT04691661 (ClinicalTrials.gov) | September 9, 2021 | 16/12/2020 | Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease | Parkinson Disease | Drug: Radotinib HCl 50 mg;Drug: Placebo | Il-Yang Pharm. Co., Ltd. | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 8 | EUCTR2020-002754-24-ES (EUCTR) | 06/07/2021 | 09/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 9 | NCT04821687 (ClinicalTrials.gov) | June 17, 2021 | 25/3/2021 | A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD | A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease | Parkinson Disease | Drug: Ongentys 50mg;Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg | SK Chemicals Co., Ltd. | NULL | Recruiting | 30 Years | N/A | All | 200 | Phase 4 | Korea, Republic of |
| 10 | NCT04986995 (ClinicalTrials.gov) | June 9, 2021 | 27/7/2021 | OpicApone Sleep dISorder | Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders | Parkinson Disease | Drug: Opicapone | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 30 | Phase 4 | Portugal |
| 11 | NCT05225324 (ClinicalTrials.gov) | June 3, 2021 | 26/1/2022 | A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg) | Equfina Tablet 50 mg Post Marketing Surveillance Protocol | Parkinson Disease | Drug: Equfina 50 mg | Eisai Korea Inc. | NULL | Recruiting | 18 Years | N/A | All | 600 | Korea, Republic of | |
| 12 | NCT04978597 (ClinicalTrials.gov) | May 31, 2021 | 5/7/2021 | Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension | Parkinson | Drug: Opicapone 50 mg;Drug: Placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | 80 Years | All | 324 | Phase 3 | Bulgaria |
| 13 | EUCTR2020-001176-15-DE (EUCTR) | 07/05/2021 | 17/12/2020 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 14 | EUCTR2018-004892-11-IT (EUCTR) | 22/04/2021 | 07/10/2020 | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients - SteP-on | •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD•A Modified Hoehn and Yahr stage of = 4 in the off” state;•A stable (4 weeks since last modification) anti-parkinsonian therapy; •The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs frozen” or glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO | OSPEDALE SANTA MARIA DELLA MISERICORDIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 3 | Italy | ||
| 15 | EUCTR2021-000867-65-DE (EUCTR) | 19/04/2021 | 16/03/2021 | Investigation of the adhesion properties of a newly developed rotigotine-containing patch in patients with Parkinson's disease | Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed rotigotine-containing transdermal patch in patients with Parkinson's disease | Idiopathic Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Product Name: ROT-TDS 8 mg/24 h INN or Proposed INN: ROTIGOTINE Trade Name: Neupro® 8 mg/24 h Product Name: Neupro® 8 mg/24 h INN or Proposed INN: ROTIGOTINE | Luye Pharma Switzerland AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 16 | EUCTR2020-001176-15-PT (EUCTR) | 19/03/2021 | 04/01/2021 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 17 | NCT04986982 (ClinicalTrials.gov) | February 25, 2021 | 27/7/2021 | OpiCapone Effect on Motor Fluctuations and pAiN | Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain. | Parkinson Disease | Drug: Opicapone 50 mg;Other: Matching placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 140 | Phase 4 | United Kingdom |
| 18 | EUCTR2019-002952-17-IT (EUCTR) | 19/02/2021 | 25/01/2021 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5 mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON Product Name: Tavapadon 0.25 mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 19 | EUCTR2020-001175-32-PT (EUCTR) | 15/01/2021 | 30/09/2020 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s disease | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone 50 mg hard capsules INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 20 | NCT04590612 (ClinicalTrials.gov) | January 2021 | 17/9/2020 | Improving Quality of Life in Early Parkinson's Disease | The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients | Parkinson Disease;Depression | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: Citalopram | Western University, Canada | NULL | Not yet recruiting | 50 Years | 80 Years | All | 30 | N/A | NULL |
| 21 | EUCTR2020-001175-32-IT (EUCTR) | 17/12/2020 | 15/06/2021 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's disease | Randomized, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson's disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 22 | NCT04724109 (ClinicalTrials.gov) | October 14, 2020 | 21/1/2021 | A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment) | Protocol for Study EQF01S: General Drug Use-Results Observational Study of Equfina® TABLETS 50 mg Observational Study on the Incidences of Adverse Drug Reactions in Patients With Parkinson's Disease (Including Patients With Hepatic Impairment) | Parkinson Disease | Drug: Equfina | Eisai Co., Ltd. | NULL | Completed | N/A | N/A | All | 1088 | Japan | |
| 23 | EUCTR2020-001175-32-GB (EUCTR) | 29/09/2020 | 07/08/2020 | Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease. | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;Italy;United Kingdom | ||
| 24 | NCT04384666 (ClinicalTrials.gov) | June 2, 2020 | 8/5/2020 | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 56 | Phase 1 | United States |
| 25 | EUCTR2019-003962-41-GB (EUCTR) | 23/03/2020 | 06/02/2020 | Trial of Ondansetron as a Parkinson's HAllucinations Treatment: TOP HAT | Trial of Ondansetron as a Parkinson’s HAllucinations Treatment - TOP HAT | Adults aged over 18 years with Parkinson's disease and visual hallucinations MedDRA version: 21.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Trade Name: Ondansetron 8 mg film-coated tablets Product Name: Ondansetron 8 mg film-coated tablets INN or Proposed INN: Ondansetron hydrochloride dihydrate | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 2 | United Kingdom | ||
| 26 | NCT04269642 (ClinicalTrials.gov) | March 19, 2020 | 13/1/2020 | SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease | Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease | Early Parkinson's Disease | Drug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mg | Peptron, Inc. | NULL | Active, not recruiting | 40 Years | 75 Years | All | 99 | Phase 2 | Korea, Republic of |
| 27 | NCT04322227 (ClinicalTrials.gov) | January 23, 2020 | 29/1/2020 | Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects | Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects | Parkinson Disease;Healthy | Drug: Foliglurax 10 mg (treatment A);Drug: Foliglurax 30 mg (treatment B);Drug: Placebo (treatment C) | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | France |
| 28 | NCT04175132 (ClinicalTrials.gov) | November 12, 2019 | 12/11/2019 | Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD) | Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: foliglurax | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | Sweden |
| 29 | EUCTR2019-000732-26-SE (EUCTR) | 23/10/2019 | 07/05/2019 | Exenatide Treatment in Parkinson's Disease | Effect of Exenatide on disease progression in early Parkinson's disease. | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Bydureon 2 mg powder and solvent for prolonged-release suspension Product Name: BYDUREON INN or Proposed INN: EXENATIDE | Stockholm Health Care Services | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Sweden | ||
| 30 | NCT03905811 (ClinicalTrials.gov) | September 24, 2019 | 1/4/2019 | A Pilot Study of Terazosin for Parkinson's Disease | A Pilot Study of Terazosin for Parkinson's Disease | Parkinson Disease | Drug: Terazosin 5 MG;Drug: Placebo oral capsule | Jordan Schultz | University of Iowa | Completed | 40 Years | 90 Years | All | 13 | Phase 1/Phase 2 | United States |
| 31 | JPRN-UMIN000037421 | 2019/08/01 | 01/08/2019 | A study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months. The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26. | Ichinomiya Nishi Hospital | NULL | Complete: follow-up continuing | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 32 | JPRN-UMIN000037422 | 2019/08/01 | 01/08/2019 | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months. | Ichinomiya Nishi Hospital | NULL | Complete: follow-up continuing | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 33 | EUCTR2018-003219-23-GB (EUCTR) | 28/06/2019 | 04/06/2019 | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease) | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD | This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Code: N/A INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Trade Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h Product Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Product Name: Rivastigmine transdermal system 13.3 mg/24 h Product Code: RIV-TDS 13.3 mg/24 h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) | University of Bristol | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Kingdom | ||
| 34 | ChiCTR1900022534 | 2019-06-01 | 2019-04-15 | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | non-motor symptoms of Parkinson’s disease | entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.; | Geriatric Hospital of Hainan | NULL | Pending | 40 | 75 | Both | entacapone group:194;pramipexole group:194; | N/A | China |
| 35 | JPRN-jRCTs031180248 | 29/05/2019 | 12/03/2019 | N/A | Intervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease - Istra adjust PD | Parkinson's disease | Arm with treatment of Istradefylline and levodopa Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 1. Dose reduction is possible if the patient has tolerability issues. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. Arm without treatment of Istradefylline 50mg levodopa will be added at Week 0. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. | Hatano Taku | Kyowa Kirin Co., Ltd | Complete | >= 30age old | <= 84age old | Both | 111 | N/A | Japan |
| 36 | NCT03958708 (ClinicalTrials.gov) | May 13, 2019 | 14/5/2019 | Modulation of Gut Microbiota by Rifaximin in PD Patients | Modulation of Gut Microbiota by Rifaximin in PD Patients | Parkinson Disease;Inflammation | Drug: Rifaximin 550 MG | Taipei Medical University Shuang Ho Hospital | NULL | Recruiting | 45 Years | 70 Years | All | 20 | Phase 1/Phase 2 | Taiwan |
| 37 | JPRN-JapicCTI-194763 | 22/4/2019 | 20/05/2019 | Safety and PK study of LY03003 | An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. | Parkinson's Disease | Intervention name : Rotigotine INN of the intervention : Rotigotine Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week. Control intervention name : Rotigotine INN of the control intervention : Rotigotine Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day. | Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd. | NULL | complete | 20 | BOTH | 32 | Phase 1 | Japan | |
| 38 | EUCTR2017-002426-20-FR (EUCTR) | 05/04/2019 | 26/11/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria | ||
| 39 | NCT03877510 (ClinicalTrials.gov) | April 3, 2019 | 12/3/2019 | Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations | An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | Parkinson Disease | Drug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 420 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 40 | NCT03865121 (ClinicalTrials.gov) | March 4, 2019 | 26/2/2019 | Pilot Trial of Transnasal Nicotine in Parkinson Disease | Uncontrolled Pilot Trial of Transnasal Nicotine in Parkinson Disease | Parkinson Disease | Drug: Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | Howard University | Completed | 60 Years | N/A | All | 6 | Phase 2 | Mexico |
| 41 | EUCTR2017-002426-20-IT (EUCTR) | 21/02/2019 | 07/10/2020 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson's Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | Germany;Italy;France;Spain;Austria | ||
| 42 | NCT04510922 (ClinicalTrials.gov) | February 11, 2019 | 9/7/2020 | Lundbeck TOMs Orthostatic Hypotension | Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study | Orthostatic Hypotension;Idiopathic Parkinson Disease | Drug: Droxidopa 100 MG [Northera] | Alberto Espay, MD, MSc | Lundbeck LLC | Completed | 30 Years | 80 Years | All | 10 | Phase 4 | United States |
| 43 | EUCTR2017-002426-20-AT (EUCTR) | 22/01/2019 | 03/12/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 4 | Spain;Austria | ||
| 44 | NCT03733561 (ClinicalTrials.gov) | November 9, 2018 | 6/11/2018 | A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 40 | Phase 1 | United States |
| 45 | JPRN-JapicCTI-184181 | 01/11/2018 | 30/10/2018 | Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term Safety | AZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety | Parkinson's disease | Intervention name : Rasagiline INN of the intervention : rasagiline Dosage And administration of the intervention : Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | complete | BOTH | 1021 | NA | Japan | ||
| 46 | EUCTR2017-002426-20-ES (EUCTR) | 19/10/2018 | 20/08/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria;Italy | ||
| 47 | NCT03665454 (ClinicalTrials.gov) | September 24, 2018 | 1/8/2018 | PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | A Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | Parkinson Disease | Drug: PF-06412562;Drug: Standard of Care Placebo | Milton S. Hershey Medical Center | Pfizer | Completed | N/A | N/A | All | 8 | Phase 1 | United States |
| 48 | NCT03773796 (ClinicalTrials.gov) | August 6, 2018 | 19/7/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy | Parkinson Disease | Drug: Nabilone 0.25 mg | Medical University Innsbruck | NULL | Recruiting | 30 Years | 100 Years | All | 48 | Phase 3 | Austria |
| 49 | JPRN-JMA-IIA00385 | 01/08/2018 | 12/09/2018 | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Parkinson's disease | Intervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value.. | Kyoto University Hospital | NULL | Completed | >=50 YEARS | <70 YEARS | BOTH | 7 | Phase 3 | Japan |
| 50 | EUCTR2018-001209-95-IT (EUCTR) | 05/07/2018 | 03/08/2021 | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001 | Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill¿ Carbidopa/levodopa Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI Product Name: Sinemet Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Spain;Italy | ||
| 51 | EUCTR2017-004006-18-NL (EUCTR) | 07/06/2018 | 15/11/2017 | The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease | Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease | Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: Madopar 125 mg, orodispersible tablet | Pharmaceutical Technology and Biopharmacy, University of Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 2 | Netherlands | ||
| 52 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 53 | NCT03541356 (ClinicalTrials.gov) | May 8, 2018 | 5/4/2018 | Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal | A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients | Parkinson's Disease | Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg | Impel NeuroPharma Inc. | NULL | Completed | 40 Years | 80 Years | All | 32 | Phase 2 | Australia |
| 54 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 55 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 56 | NCT04265027 (ClinicalTrials.gov) | February 20, 2018 | 7/2/2020 | Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) | An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers. | Parkinson Disease | Drug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg Ongentys | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United Kingdom |
| 57 | JPRN-UMIN000030930 | 2018/01/29 | 01/01/2019 | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease | Parkinson's disease | Administration of febuxostat 20 mg and inosine 500 mg twice a day for 58 days | StaGen Co. Ltd. | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
| 58 | NCT03769896 (ClinicalTrials.gov) | October 3, 2017 | 6/12/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study | Parkinson Disease | Drug: Nabilone 0.25 mg;Drug: Placebo | Medical University Innsbruck | NULL | Completed | 30 Years | 100 Years | All | 48 | Phase 2 | Austria |
| 59 | NCT03185481 (ClinicalTrials.gov) | July 6, 2017 | 9/6/2017 | Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease With Motor Fluctuations | Drug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD | Pfizer | NULL | Terminated | 40 Years | 87 Years | All | 5 | Phase 2 | United States |
| 60 | EUCTR2015-004507-23-FI (EUCTR) | 08/05/2017 | 30/03/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 61 | ChiCTR-IPR-17011155 | 2017-04-20 | 2017-04-16 | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Parkinson’s disease | treatment group:dihydroergotoxine mesylate 2.5 mg, twice daily, two weeks;intervention group:identical placebo 2.5 mg, twice daily, two weeks; | Nanjing First Hospital Affiliated to Nanjing Medical University | NULL | Recruiting | 18 | 80 | Both | treatment group:10;intervention group:10; | China | |
| 62 | EUCTR2016-004629-18-NL (EUCTR) | 13/04/2017 | 17/01/2017 | The influence of stress on Parkinson's tremor | The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor | Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Propranolol Product Name: Propranolol HCl CF 40 mg tablet Product Code: RVG 55618 | Radboud University Nijmegen | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Netherlands | ||
| 63 | JPRN-jRCTs051180185 | 07/04/2017 | 26/03/2019 | APISJ Study | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study | Parkinson's disease Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline. | Takahashi Makio | Kyowa Kirin Co., Ltd. | Complete | >= 30age old | Not applicable | Both | 30 | N/A | Japan |
| 64 | JPRN-UMIN000026492 | 2017/03/15 | 15/03/2017 | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Osaka Red Cross Hospital | Clinical Research Center, Wakayama Medical University | Complete: follow-up complete | 30years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 65 | EUCTR2015-003513-24-SK (EUCTR) | 14/03/2017 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 66 | JPRN-jRCTs071180014 | 08/03/2017 | 29/01/2019 | ODYSSEI Study | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study | Parkinson's disease Parkinson's disease | Arm A: Treatment with Istradefylline combined with optimal medical therapy. Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient. Arm B: Optimal medical therapy without Istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient. | Tsuboi Yoshio | Kyowa Kirin Co., Ltd. | Not Recruiting | >= 30age old | < 80age old | Both | 280 | N/A | N A;Japan |
| 67 | EUCTR2015-004507-23-HU (EUCTR) | 24/02/2017 | 04/01/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 68 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Germany;United Kingdom | ||
| 69 | JPRN-UMIN000024536 | 2016/11/28 | 25/10/2016 | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) | Parkinson's disease | Treatment with istradefylline combined with optimal medical therapy. Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient. Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient. | Fukuoka University | NULL | Complete: follow-up complete | 30years-old | 80years-old | Male and Female | 280 | Not applicable | Japan |
| 70 | EUCTR2016-001690-33-FI (EUCTR) | 25/11/2016 | 23/11/2016 | Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa | Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa | Edennyt parkinsonin tauti MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dacepton 5 mg/ml infuusioneste, liuos Product Name: Dacepton 5 mg/ml | Eero Pekkonen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland | |||
| 71 | NCT02910102 (ClinicalTrials.gov) | October 2016 | 16/9/2016 | Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia | A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia | Alzheimer's Disease;Dementia With Lewy Bodies;Parkinson's Disease Dementia | Drug: RVT-101 35 mg;Drug: Placebo | Axovant Sciences Ltd. | NULL | Completed | 50 Years | 89 Years | All | 38 | Phase 2 | United States |
| 72 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on CNS diseases | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan |
| 73 | EUCTR2015-003513-24-DE (EUCTR) | 08/09/2016 | 15/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 74 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Germany;Italy;United Kingdom | ||
| 75 | EUCTR2015-003513-24-BG (EUCTR) | 27/06/2016 | 26/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 76 | EUCTR2015-003513-24-IT (EUCTR) | 23/06/2016 | 05/11/2020 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 77 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 78 | JPRN-jRCTs051180098 | 09/06/2016 | 06/03/2019 | The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease | A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease | Parkinson's disease;034034 | L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365. | Ito Hidefumi | NULL | Not Recruiting | >= 55age old | < 80age old | Both | 120 | Phase 2 | Japan |
| 79 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 80 | JPRN-UMIN000022533 | 2016/06/01 | 01/06/2016 | A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease | A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease - The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease(DATSZ-PD study) | Parkinson's disease | L-Dopa/DCI only The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + selegiline L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + zonisamide L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365. | Osaka Redcross HospitalWakayama Prefectural Medical College | NULL | Recruiting | 55years-old | 80years-old | Male and Female | 180 | Phase 2 | Japan |
| 81 | JPRN-UMIN000009062 | 2016/05/30 | 09/10/2012 | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease - An evaluation of the safety of inosine for patients with Parkinson's disease | Parkinson's disease | Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL | Dept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 1 | Japan |
| 82 | EUCTR2015-003513-24-HU (EUCTR) | 24/05/2016 | 02/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 83 | EUCTR2015-003513-24-ES (EUCTR) | 18/05/2016 | 18/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 84 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 85 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 86 | JPRN-UMIN000022187 | 2016/05/06 | 06/05/2016 | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease - Analysis of caffeine absorption in patients with Parkinson's disease | Parkinson's disease | PD group, 200 mg caffeine administration, qd, 1 day Control group, 200 mg caffeine administration, qd, 1 day | Department of Neurology, Juntendo University | NULL | Complete: follow-up complete | 40years-old | 60years-old | Male and Female | 20 | Not applicable | Japan |
| 87 | NCT02728947 (ClinicalTrials.gov) | May 2016 | 31/3/2016 | Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | Parkinson's Disease | Drug: ROTIGOTINE | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 99 Years | Both | 28 | Phase 1 | United States |
| 88 | EUCTR2015-003513-24-GB (EUCTR) | 28/04/2016 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 89 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 90 | EUCTR2015-004507-23-DE (EUCTR) | 25/04/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 91 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 92 | EUCTR2014-005562-30-IT (EUCTR) | 18/04/2016 | 04/11/2020 | Citicoline as supportive treatment in Parkinson's disease | Role of citicoline as supportive therapy in Parkinson’s disease. - CITIPARK | Parkinson's disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CITICOLIN*1G/4ML IM IV 5 F Product Name: Citicolina 1000 mg/die Product Code: [citicolin] INN or Proposed INN: CITICOLINA SODICA | PIAM FARMACEUTICI S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 474 | Phase 4 | Italy | ||
| 93 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
| 94 | JPRN-jRCTs061180060 | 22/03/2016 | 18/03/2019 | Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease;D010300 | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) | Nagai Masahiro | NULL | Complete | >= 20age old | Not applicable | Both | 100 | Phase 2 | Japan |
| 95 | EUCTR2015-003679-31-ES (EUCTR) | 21/03/2016 | 13/01/2016 | New therapeutic strategy in Parkinson?s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone - FAIRPARK II | De Novo Parkinson?s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ferriprox 500 mg Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 338 | Phase 3 | Spain | ||
| 96 | EUCTR2015-004507-23-LV (EUCTR) | 15/03/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC | Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Finland;Germany;Latvia | ||
| 97 | NCT02687542 (ClinicalTrials.gov) | March 3, 2016 | 29/1/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD) | Pfizer | NULL | Terminated | 40 Years | 85 Years | All | 108 | Phase 2 | United States;Canada;France;Germany;Japan;Spain |
| 98 | JPRN-UMIN000020288 | 2016/02/01 | 28/12/2015 | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. - Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Juntendo University Shizuoka Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 99 | JPRN-UMIN000020527 | 2016/02/01 | 01/02/2016 | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Parkinson's disease | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years | Ehime University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Phase 2 | Japan |
| 100 | NCT02649608 (ClinicalTrials.gov) | January 2016 | 6/1/2016 | An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients | Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease | Parkinson Disease | Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621;Drug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621 | H. Lundbeck A/S | NULL | Completed | 45 Years | 75 Years | All | 15 | Phase 1 | United States |
| 101 | EUCTR2014-002600-24-AT (EUCTR) | 30/12/2015 | 25/09/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 102 | EUCTR2014-002600-24-IT (EUCTR) | 11/12/2015 | 16/02/2018 | Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 103 | EUCTR2014-002600-24-SE (EUCTR) | 03/12/2015 | 30/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 104 | NCT02610231 (ClinicalTrials.gov) | December 2015 | 13/11/2015 | Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 20 mg or 40 mg | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 239 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 105 | EUCTR2014-002600-24-ES (EUCTR) | 19/11/2015 | 05/10/2015 | Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 106 | JPRN-UMIN000019676 | 2015/11/10 | 10/11/2015 | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | Parkinson's disease | taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 20 | Not selected | Japan |
| 107 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 108 | EUCTR2014-002600-24-GB (EUCTR) | 03/11/2015 | 28/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 109 | NCT02271503 (ClinicalTrials.gov) | November 2015 | 13/10/2014 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease | A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease | Parkinson's Disease | Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 26 | Phase 2 | United States |
| 110 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 111 | NCT02337751 (ClinicalTrials.gov) | July 10, 2015 | 9/1/2015 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 198 | Phase 3 | Japan |
| 112 | NCT02337725 (ClinicalTrials.gov) | February 7, 2015 | 9/1/2015 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 80 Years | All | 244 | Phase 3 | Japan |
| 113 | JPRN-JapicCTI-152762 | 03/2/2015 | 06/01/2015 | A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's disease | Intervention name : TVP-1012 (1 mg/day) with levodopa INN of the intervention : - Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 30 | 79 | BOTH | 222 | Phase 3 | Japan |
| 114 | NCT02337764 (ClinicalTrials.gov) | February 3, 2015 | 9/1/2015 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 222 | Phase 3 | Japan |
| 115 | NCT02337738 (ClinicalTrials.gov) | January 27, 2015 | 9/1/2015 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off | Parkinson's Disease | Drug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 79 Years | All | 404 | Phase 2/Phase 3 | Japan |
| 116 | EUCTR2014-004501-32-NL (EUCTR) | 11/12/2014 | 03/12/2014 | Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments | Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation) | Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 117 | EUCTR2014-002295-87-IT (EUCTR) | 13/10/2014 | 29/09/2014 | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | Parkinson's disease patients who suffer motor fluctuations willparticipate in the study MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg compresse Product Name: SINEMET 100 mg + 25 mg compresse Product Code: NA | SynAgile Corporation | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 118 | NCT02225548 (ClinicalTrials.gov) | September 2014 | 22/8/2014 | Sagene 2014 - Parkinson's Disease and Erectile Dysfunction | An Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction. | Parkinson's Disease;Erectile Dysfunction | Drug: Selegiline;Drug: Tadalafil | University of South Florida | NULL | Recruiting | 40 Years | 64 Years | Male | 10 | Phase 4 | United States |
| 119 | NCT02174250 (ClinicalTrials.gov) | June 2014 | 24/6/2014 | The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers. | Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects | Parkinson's Disease | Drug: Istradefylline 40 mg;Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only | Kyowa Hakko Kirin Pharma, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 20 | Phase 1 | United States |
| 120 | EUCTR2013-002254-70-PL (EUCTR) | 28/04/2014 | 03/02/2014 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 121 | EUCTR2013-002254-70-CZ (EUCTR) | 05/03/2014 | 02/12/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 122 | NCT02111330 (ClinicalTrials.gov) | March 2014 | 20/3/2014 | Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Parkinson Disease | Drug: PBF-509;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Palo Biofarma, S.L | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Spain |
| 123 | EUCTR2013-002254-70-DE (EUCTR) | 28/02/2014 | 19/11/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 124 | EUCTR2013-002254-70-IT (EUCTR) | 21/02/2014 | 27/11/2013 | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Hakko Kirin Pharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 125 | NCT01968460 (ClinicalTrials.gov) | December 2013 | 15/10/2013 | Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | Parkinson's Disease | Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), | Pharma Two B Ltd. | NULL | Completed | 35 Years | 75 Years | All | 149 | Phase 2/Phase 3 | United States;Israel |
| 126 | NCT01968031 (ClinicalTrials.gov) | October 2013 | 18/10/2013 | A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 40 mg;Drug: Istradefylline 20 mg;Drug: Placebo | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 613 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 127 | EUCTR2012-001245-40-IT (EUCTR) | 05/06/2013 | 17/05/2013 | CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | PARKINSON'S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Madopar 200+50 mg Trade Name: LEVODOPA / BENSERAZIDE 200 + 50 MG | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 128 | NCT01879748 (ClinicalTrials.gov) | June 2013 | 13/6/2013 | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline | A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 20 Years | 50 Years | Both | 64 | Phase 1 | United States |
| 129 | JPRN-UMIN000046104 | 2013/03/01 | 21/11/2021 | Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease | Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease - RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya | Parkinson's disease | This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen. During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences. | Nagoya City University | NULL | Complete: follow-up complete | 60years-old | 75years-old | Male and Female | 12 | Not applicable | Japan |
| 130 | NCT01603069 (ClinicalTrials.gov) | October 2012 | 14/5/2012 | A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: Placebo | AstraZeneca | NULL | Completed | 30 Years | 80 Years | Both | 51 | Phase 2 | United States |
| 131 | EUCTR2011-004803-19-FI (EUCTR) | 16/08/2012 | 16/05/2012 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 132 | NCT01602549 (ClinicalTrials.gov) | July 2012 | 17/5/2012 | A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | Gastroparesis | Drug: GSK962040 (25 mg tablet);Drug: Placebo | GlaxoSmithKline | NULL | Completed | 40 Years | 80 Years | All | 58 | Phase 2 | Australia;Germany;Sweden;United Kingdom |
| 133 | JPRN-UMIN000007896 | 2012/05/01 | 07/05/2012 | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Parkinson's disease and other parkinsonian syndromes | The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. | Kansai Medical University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan |
| 134 | EUCTR2012-000181-37-GB (EUCTR) | 25/04/2012 | 27/02/2012 | A study investigating the safety of CVT-301 in patients with Parkinson's Disease | A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Israel;United Kingdom | ||
| 135 | NCT01527695 (ClinicalTrials.gov) | April 2012 | 22/12/2011 | PET Study in Parkinson's Disease Patients | A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mg | AstraZeneca | NULL | Completed | 45 Years | 75 Years | Both | 24 | Phase 2 | Sweden |
| 136 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 137 | EUCTR2011-004803-19-SE (EUCTR) | 22/02/2012 | 16/12/2011 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 138 | EUCTR2011-005054-59-RO (EUCTR) | 21/02/2012 | 13/06/2013 | SYN115 in Parkinson’s disease | A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none) | Parkinson’s disease MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SYN115 Tablets, 60 mg Product Code: SYN115 INN or Proposed INN: tozadenant Other descriptive name: tozadenant | Biotie Therapies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | United States;Canada;Argentina;Ukraine;Romania;Chile | |||
| 139 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 140 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 141 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODO | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 142 | EUCTR2011-002901-31-GB (EUCTR) | 25/11/2011 | 21/09/2011 | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: Oxycodone hydrochloride INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 143 | NCT01457807 (ClinicalTrials.gov) | November 2011 | 10/10/2011 | To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers | A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers | Parkinson's Disease | Drug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 | AstraZeneca | NULL | Completed | 30 Years | 65 Years | Both | 24 | Phase 1 | United Kingdom |
| 144 | NCT02170376 (ClinicalTrials.gov) | September 2011 | 19/6/2014 | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopa | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | France |
| 145 | EUCTR2010-020299-42-DE (EUCTR) | 30/08/2011 | 26/04/2011 | A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients. | A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD | Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE | Philipps-University Marburg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Germany | ||
| 146 | EUCTR2007-002964-90-BE (EUCTR) | 05/05/2011 | 04/09/2007 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 147 | NCT01283594 (ClinicalTrials.gov) | March 2011 | 24/1/2011 | Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off | A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off | Parkinson's Disease | Drug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BID | Biotie Therapies Inc. | NULL | Completed | 30 Years | 80 Years | All | 420 | Phase 2/Phase 3 | United States;Argentina;Canada;Chile;Romania;Ukraine |
| 148 | EUCTR2008-001329-33-GB (EUCTR) | 24/02/2011 | 15/03/2010 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom | ||
| 149 | EUCTR2010-021394-37-ES (EUCTR) | 17/02/2011 | 22/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy | ||
| 150 | EUCTR2010-022915-21-SE (EUCTR) | 12/01/2011 | 18/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 151 | EUCTR2010-022915-21-FI (EUCTR) | 10/01/2011 | 11/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 152 | EUCTR2008-004146-88-DE (EUCTR) | 20/12/2010 | 15/10/2010 | An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 153 | EUCTR2007-002964-90-CZ (EUCTR) | 06/10/2010 | 27/08/2010 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 154 | NCT01155466 (ClinicalTrials.gov) | July 14, 2010 | 30/6/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938) | Parkinson Disease | Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsule | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 778 | Phase 3 | Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States |
| 155 | NCT01155479 (ClinicalTrials.gov) | July 6, 2010 | 30/6/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease | Parkinson Disease | Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo for Rasagiline 1 mg capsule;Drug: Placebo for Preladenant | Merck Sharp & Dohme Corp. | NULL | Terminated | 30 Years | 85 Years | All | 1022 | Phase 3 | Argentina;Bulgaria;Canada;Chile;Colombia;Czech Republic;Finland;France;Germany;Hungary;India;Israel;Italy;Mexico;Peru;Poland;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States |
| 156 | NCT01096186 (ClinicalTrials.gov) | March 2010 | 25/3/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mg | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 617 | Phase 3 | United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine |
| 157 | EUCTR2007-002963-28-DE (EUCTR) | 17/02/2010 | 22/12/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 158 | NCT02169414 (ClinicalTrials.gov) | February 2010 | 24/1/2012 | Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics | Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa/carbidopa 100/25;Drug: Placebo;Drug: levodopa/benserazide 100/25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 74 | Phase 1 | France |
| 159 | NCT01568047 (ClinicalTrials.gov) | February 2010 | 29/3/2012 | Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients | Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon) | Parkinson's Disease | Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 40 | Phase 2 | Romania;Ukraine |
| 160 | EUCTR2008-001329-33-CZ (EUCTR) | 18/01/2010 | 03/12/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy | ||
| 161 | EUCTR2009-012419-16-DE (EUCTR) | 03/12/2009 | 20/10/2009 | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | idiopathic Parkinson's disease MedDRA version: 12.0;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Clarium 50 mg Retardtabletten INN or Proposed INN: piribedil | Desitin Arzneimittel GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 162 | NCT01070628 (ClinicalTrials.gov) | December 2009 | 23/11/2009 | Levodopa Concentration Profile With Stalevo 75/125 mg | Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups | Parkinson's Disease | Drug: Stalevo (levodopa/ carbidopa/ entacapone);Drug: Sinemet (levodopa/carbidopa) | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 1 | Finland |
| 163 | NCT01519284 (ClinicalTrials.gov) | November 2009 | 23/1/2012 | Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic | A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 82 | Phase 1 | Portugal |
| 164 | EUCTR2008-004146-88-PL (EUCTR) | 19/10/2009 | 31/08/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 165 | EUCTR2008-001329-33-PT (EUCTR) | 02/10/2009 | 19/08/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 275 | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand | |||
| 166 | NCT01028586 (ClinicalTrials.gov) | October 2009 | 7/12/2009 | MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) | A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide, MAO-B inhibitor;Drug: Placebo | Newron | NULL | Terminated | 30 Years | 80 Years | Both | 507 | Phase 3 | Switzerland |
| 167 | NCT01371682 (ClinicalTrials.gov) | September 18, 2009 | 10/6/2010 | A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda | An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda | Parkinson Disease | Drug: Ropinirole XL | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | All | 50 | Phase 1 | Belgium |
| 168 | NCT00794313 (ClinicalTrials.gov) | September 2009 | 19/11/2008 | Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease | Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease | Parkinson's Disease | Drug: Amantadine 300 mg;Drug: Topiramate;Drug: Sugar Pill | Oregon Health and Science University | NULL | Terminated | 21 Years | N/A | All | 3 | N/A | United States |
| 169 | EUCTR2009-011541-24-ES (EUCTR) | 27/08/2009 | 26/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | Parkinson's Disease Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT 1 mg comprimidos INN or Proposed INN: RASAGILINA MESILATO Other descriptive name: RASAGILINA MESILATO | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 170 | EUCTR2008-004146-88-BG (EUCTR) | 13/08/2009 | 13/07/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 171 | EUCTR2008-004146-88-PT (EUCTR) | 31/07/2009 | 14/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 172 | EUCTR2008-004146-88-ES (EUCTR) | 16/06/2009 | 16/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 173 | EUCTR2008-001966-10-EE (EUCTR) | 16/06/2009 | 13/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 174 | EUCTR2008-004146-88-CZ (EUCTR) | 08/06/2009 | 07/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 175 | EUCTR2008-001966-10-AT (EUCTR) | 27/05/2009 | 08/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 176 | EUCTR2008-004146-88-IT (EUCTR) | 26/05/2009 | 27/04/2009 | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | Idiopatic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Safinamide INN or Proposed INN: Safinamide Product Name: Safinamide INN or Proposed INN: Safinamide | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 177 | EUCTR2008-004146-88-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 178 | EUCTR2008-001966-10-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Other descriptive name: NW-1015 Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Estonia;Hungary;Slovakia;Austria;United Kingdom | ||
| 179 | EUCTR2008-004146-88-FI (EUCTR) | 19/05/2009 | 06/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 180 | EUCTR2008-001966-10-GB (EUCTR) | 12/05/2009 | 27/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 181 | EUCTR2006-000578-53-DE (EUCTR) | 08/05/2009 | 30/10/2008 | Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 70 | United States;Germany;New Zealand | |||
| 182 | EUCTR2008-001966-10-HU (EUCTR) | 04/05/2009 | 06/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 183 | EUCTR2007-002963-28-BG (EUCTR) | 03/05/2009 | 21/05/2009 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 184 | NCT00845000 (ClinicalTrials.gov) | April 21, 2009 | 13/2/2009 | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients | Parkinson Disease | Drug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa | Merck Sharp & Dohme Corp. | Oregon Health and Science University | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 185 | EUCTR2007-002964-90-AT (EUCTR) | 02/04/2009 | 13/02/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 186 | EUCTR2007-002963-28-PL (EUCTR) | 02/04/2009 | 27/02/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 187 | JPRN-JapicCTI-090888 | 01/4/2009 | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | Parkinson's Disease Treated Concomitantly with L-dopa | Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. | Otsuka Pharmaceutical Co., Ltd. | NULL | 30 | 79 | BOTH | 400 | Phase 3 | NULL | ||
| 188 | NCT00880620 (ClinicalTrials.gov) | April 2009 | 3/4/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine |
| 189 | EUCTR2008-004447-11-GB (EUCTR) | 27/03/2009 | 07/01/2009 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;United Kingdom;Italy | ||
| 190 | EUCTR2007-002963-28-PT (EUCTR) | 26/03/2009 | 07/01/2009 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 191 | EUCTR2007-002964-90-FR (EUCTR) | 09/03/2009 | 12/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 192 | NCT01533116 (ClinicalTrials.gov) | March 2009 | 24/1/2012 | Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide | Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazide | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | All | 52 | Phase 1 | Canada |
| 193 | NCT00870974 (ClinicalTrials.gov) | March 2009 | 26/3/2009 | A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions | Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions | Parkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive Impairment | Drug: [18F]FPEB | Institute for Neurodegenerative Disorders | NULL | Completed | 18 Years | 85 Years | All | 48 | Phase 1 | United States |
| 194 | NCT01533077 (ClinicalTrials.gov) | March 2009 | 24/1/2012 | Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa | Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Sinemet® 100/25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 18 | Phase 1 | Canada |
| 195 | EUCTR2008-006278-13-NL (EUCTR) | 04/02/2009 | 15/10/2008 | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | patients with advanced (>5 years) Parkinson's disease and visual hallucinations. MedDRA version: 9.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations MedDRA version: 9.1;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Reminyl Retard Trade Name: Sinemet 125 mg | UMCG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Netherlands | |||
| 196 | NCT00627640 (ClinicalTrials.gov) | February 2009 | 13/2/2008 | Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa | A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine | Idiopathic Parkinson's Disease | Drug: Safinimide 50-100 mg/day;Drug: Matching Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 549 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom |
| 197 | EUCTR2007-002963-28-CZ (EUCTR) | 19/01/2009 | 30/10/2007 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 198 | NCT02169466 (ClinicalTrials.gov) | January 2009 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Portugal |
| 199 | EUCTR2008-003966-25-DE (EUCTR) | 23/12/2008 | 04/11/2008 | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Trade Name: Desmotabs® 0,2 mg Tabletten Product Name: Desmotabs® 0,2mg Tabletten INN or Proposed INN: Desmopressin Acetat | Universität Mainz, Klinik und Poliklinik für Neurologie | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 200 | NCT00809302 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) | Early Parkinson Disease | Drug: aplindore MR tablets or Placebo | Neurogen Corporation | NULL | Terminated | 30 Years | N/A | Both | 9 | Phase 2 | United States |
| 201 | EUCTR2007-004890-24-PT (EUCTR) | 07/10/2008 | 25/06/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| 202 | NCT02169453 (ClinicalTrials.gov) | October 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 12 | Phase 1 | Canada |
| 203 | NCT02169479 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 204 | NCT02169895 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa® | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 205 | EUCTR2008-001336-13-FR (EUCTR) | 16/07/2008 | 09/06/2008 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Maladie Parkinson MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Nicorette 5 mg/ 16 h Product Name: Nicorette 5 mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 10mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 15 mg/ 16 h INN or Proposed INN: Nicotine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 206 | EUCTR2007-002963-28-IT (EUCTR) | 30/06/2008 | 04/01/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: safinamide Product Name: safinamide | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 666 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 207 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
| 208 | EUCTR2007-002964-90-HU (EUCTR) | 03/06/2008 | 15/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A.-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 209 | EUCTR2007-004890-24-FR (EUCTR) | 07/05/2008 | 09/05/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
| 210 | EUCTR2006-006752-35-DE (EUCTR) | 06/05/2008 | 23/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 211 | NCT00605553 (ClinicalTrials.gov) | April 2008 | 15/1/2008 | Study to Evaluate SYN115 in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: Tozadenant | Biotie Therapies Inc. | NULL | Completed | 40 Years | 75 Years | All | 30 | Phase 2 | United States |
| 212 | EUCTR2007-002964-90-GB (EUCTR) | 20/03/2008 | 14/01/2009 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 213 | NCT00761137 (ClinicalTrials.gov) | March 2008 | 25/9/2008 | Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | Sialorrhea Secondary to Parkinson's Disease | Drug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamide | NeuroHealing Pharmaceuticals Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 50 Years | 80 Years | All | 19 | Phase 2 | Argentina |
| 214 | EUCTR2007-002964-90-DE (EUCTR) | 28/02/2008 | 17/12/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 484 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom | ||
| 215 | EUCTR2007-002964-90-EE (EUCTR) | 13/02/2008 | 02/01/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 216 | EUCTR2007-000350-31-ES (EUCTR) | 13/02/2008 | 21/12/2007 | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | France;Spain;Italy | ||
| 217 | EUCTR2007-000350-31-FR (EUCTR) | 22/01/2008 | 25/10/2007 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | Mild to moderately severe dementia associated with Parkinson’s disease (PDD). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 218 | EUCTR2007-002964-90-ES (EUCTR) | 18/01/2008 | 30/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 219 | EUCTR2007-002963-28-ES (EUCTR) | 17/01/2008 | 16/11/2007 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 220 | EUCTR2007-002963-28-FI (EUCTR) | 12/12/2007 | 18/10/2007 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany | ||
| 221 | EUCTR2007-002964-90-NL (EUCTR) | 11/12/2007 | 11/12/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 222 | EUCTR2007-002963-28-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 223 | EUCTR2007-002964-90-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 224 | EUCTR2007-002964-90-FI (EUCTR) | 04/12/2007 | 18/10/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 225 | NCT00537017 (ClinicalTrials.gov) | November 23, 2007 | 27/9/2007 | Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) | A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175) | Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain Diseases | Drug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatments | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | N/A | All | 140 | Phase 2 | Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States |
| 226 | EUCTR2007-002496-14-FI (EUCTR) | 05/11/2007 | 14/09/2007 | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Stalevo® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 227 | ChiCTR-TRC-07000027 | 2007-11-01 | 2007-11-09 | A randomized controlled clinical study of Pramipexole for Parkinson's disease | A randomized controlled clinical study of Pramipexole for Parkinson's disease | Primary Parkinson's disease | Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease; | First Affiliated Hospital of Xinjiang Medical University | NULL | Completed | 30 | 80 | Both | Group 1:45;Group 3:45;Group 2:45; | China | |
| 228 | NCT00605683 (ClinicalTrials.gov) | November 2007 | 19/12/2007 | MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist | A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide (as add-on therapy) | Newron | NULL | Completed | 30 Years | 80 Years | Both | 679 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel |
| 229 | EUCTR2007-001717-42-FR (EUCTR) | 25/10/2007 | 11/09/2007 | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Product Name: SCH 420814 Product Code: N/A | Schering Plough Research Institute | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Spain | ||
| 230 | NCT00642928 (ClinicalTrials.gov) | October 2007 | 21/3/2008 | Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients | Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD) | Excessive Daytime Sleepiness;Parkinson's Disease | Drug: Placebo;Drug: BF 2.649 5 mg;Drug: BF 2.649 10 mg;Drug: BF 2.649 20 mg;Drug: BF 2.649 40 mg | Bioprojet | NULL | Completed | 18 Years | N/A | Both | 108 | Phase 2 | France |
| 231 | EUCTR2007-003512-57-FR (EUCTR) | 24/08/2007 | 23/07/2007 | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 | Bioprojet | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | France | ||
| 232 | EUCTR2006-006752-35-GB (EUCTR) | 23/07/2007 | 13/01/2009 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 233 | EUCTR2006-006752-35-HU (EUCTR) | 22/06/2007 | 12/04/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 234 | EUCTR2006-005438-19-DE (EUCTR) | 12/06/2007 | 28/03/2007 | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | idiopathic Parkinson´s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch INN or Proposed INN: Rotigotine | SCHWARZ PHARMA Deutschland GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| 235 | EUCTR2006-005861-21-IT (EUCTR) | 11/06/2007 | 05/01/2007 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Italy | ||
| 236 | EUCTR2006-006752-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 237 | EUCTR2006-006752-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 238 | EUCTR2006-006752-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 239 | NCT00459420 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Parkinson's Disease;Excessive Daytime Somnolence | Drug: Caffeine 100-200 mg BID;Drug: placebo | Ron Postuma | Canadian Institutes of Health Research (CIHR);University of Toronto | Completed | 18 Years | N/A | Both | 58 | Phase 2/Phase 3 | Canada |
| 240 | NCT01187966 (ClinicalTrials.gov) | January 2007 | 31/5/2010 | Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease | A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 669 | Phase 3 | NULL |
| 241 | EUCTR2005-000314-12-DE (EUCTR) | 19/12/2006 | 25/01/2007 | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
| 242 | EUCTR2006-005860-14-IT (EUCTR) | 19/12/2006 | 17/03/2009 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy | ||
| 243 | EUCTR2006-005140-89-NL (EUCTR) | 11/12/2006 | 01/12/2006 | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536 | Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate | TEVA Pharmaceuticals Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Netherlands | ||
| 244 | NCT01964573 (ClinicalTrials.gov) | December 2006 | 14/10/2013 | Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects | A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subjects | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 19 Years | 45 Years | Both | 48 | Phase 1 | Korea, Republic of |
| 245 | NCT00402233 (ClinicalTrials.gov) | November 2006 | 19/11/2006 | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 31 Years | N/A | All | 312 | Phase 4 | United States |
| 246 | EUCTR2005-005146-39-IT (EUCTR) | 14/09/2006 | 06/12/2006 | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | Moderate to severe Parkinson s disease with motor fluctuation and dyskinesias. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Code: SCH 420814 Product Code: SCH 420814 | Schering Plough Research Institute | NULL | Not Recruiting | Female: yes Male: yes | 160 | Italy | |||
| 247 | NCT00368108 (ClinicalTrials.gov) | August 2006 | 22/8/2006 | Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparator | Eisai Inc. | NULL | Completed | 30 Years | N/A | All | 752 | Phase 3 | United States;Canada |
| 248 | EUCTR2006-000391-32-NL (EUCTR) | 18/07/2006 | 10/05/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Germany;Netherlands;United Kingdom | ||
| 249 | NCT03097211 (ClinicalTrials.gov) | July 17, 2006 | 27/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Nebicapone | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 38 | Phase 1 | Portugal |
| 250 | EUCTR2006-000391-32-DE (EUCTR) | 04/07/2006 | 27/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Netherlands | |||
| 251 | EUCTR2006-000391-32-GB (EUCTR) | 06/06/2006 | 21/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Netherlands;Germany;United Kingdom | ||
| 252 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 253 | EUCTR2005-001006-12-AT (EUCTR) | 02/04/2006 | 28/02/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 254 | EUCTR2005-001032-72-CZ (EUCTR) | 16/02/2006 | 12/01/2006 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Trade Name: Stalevo 100 mg/25 mg / 200 mg Product Code: ELC200 Trade Name: SINEMET CR Product Name: SINEMET CR | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | ||||
| 255 | NCT03095105 (ClinicalTrials.gov) | January 24, 2006 | 23/3/2017 | Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects | An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol) | Parkinson Disease | Drug: 200 mg BIA 6-512 | Bial - Portela C S.A. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 1 | Germany |
| 256 | NCT02772614 (ClinicalTrials.gov) | January 2006 | 12/5/2016 | Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration | Parkinson's Disease | Drug: BIA 3-202 (200 mg) | Bial - Portela C S.A. | NULL | Completed | 40 Years | 55 Years | Male | 4 | Phase 1 | Switzerland |
| 257 | NCT00279825 (ClinicalTrials.gov) | January 2006 | 18/1/2006 | Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 16 | Phase 2 | United States |
| 258 | NCT00292227 (ClinicalTrials.gov) | January 2006 | 14/2/2006 | Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease | Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial. | Parkinson's Disease | Drug: Rotigotine;Other: Placebo;Drug: Moxifloxacin infusion;Other: Placebo infusion | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 130 | Phase 1 | South Africa |
| 259 | EUCTR2005-002432-10-MT (EUCTR) | 25/11/2005 | 10/10/2005 | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | Parkinson Disease late stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 60 | Malta | |||
| 260 | EUCTR2005-000444-84-GB (EUCTR) | 23/11/2005 | 13/09/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 261 | EUCTR2005-002010-38-DE (EUCTR) | 21/11/2005 | 10/02/2006 | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Advanced Parkinson´s Disease | Product Name: Trivastal Product Code: S 90049 INN or Proposed INN: Piribedil | Institut de Recherches Internationales Servier (I.R.I.S.) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 262 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 263 | EUCTR2005-000314-12-ES (EUCTR) | 14/10/2005 | 08/09/2005 | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
| 264 | NCT00239564 (ClinicalTrials.gov) | October 2005 | 13/10/2005 | Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 100 mg;Drug: IPX054 150 mg;Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: IPX054 300 mg | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 1/Phase 2 | United States |
| 265 | NCT00134251 (ClinicalTrials.gov) | October 2005 | 22/8/2005 | Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease | Parkinson's Disease | Drug: SLV308 | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | Phase 3 | Bulgaria;Malta;Serbia;Former Serbia and Montenegro | |
| 266 | EUCTR2005-000444-84-FI (EUCTR) | 08/09/2005 | 26/07/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;United Kingdom;Spain;Italy | ||
| 267 | NCT02778594 (ClinicalTrials.gov) | September 2005 | 18/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide (Madopar® HBS 125): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy Volunteers | Parkinson's Disease (PD) | Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 17 | Phase 1 | Portugal |
| 268 | NCT02774564 (ClinicalTrials.gov) | September 2005 | 13/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single Dose of Controlled-release 200/50 mg Levodopa/Carbidopa (Sinemet® cr 200/50): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Portugal |
| 269 | NCT00165789 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 270 | NCT00134966 (ClinicalTrials.gov) | August 2005 | 23/8/2005 | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa | A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa | Parkinson's Disease | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Novartis | NULL | Completed | 30 Years | 80 Years | All | 493 | Phase 3 | United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic |
| 271 | EUCTR2004-002844-93-AT (EUCTR) | 20/07/2005 | 15/06/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | |||
| 272 | EUCTR2004-000835-27-ES (EUCTR) | 18/07/2005 | 23/05/2006 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.P.A | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 3 | Spain;Italy | ||
| 273 | EUCTR2005-000444-84-ES (EUCTR) | 12/07/2005 | 22/05/2006 | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | Treatment- Associated Dyskinesia in Parkinson´s Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 274 | EUCTR2004-002844-93-IT (EUCTR) | 06/07/2005 | 21/09/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. - | Parkinson's Disease. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Istradefylline Product Code: KW-6002 Other descriptive name: NA | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | |||||
| 275 | EUCTR2005-000444-84-AT (EUCTR) | 22/06/2005 | 18/05/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 276 | NCT00642889 (ClinicalTrials.gov) | June 2005 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension) | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 227 | Phase 3 | NULL |
| 277 | NCT03095092 (ClinicalTrials.gov) | May 23, 2005 | 23/3/2017 | Effect of Food on BIA 6-512 (Trans-resveratrol) | The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy Subjects | Parkinson Disease | Drug: BIA 6-512 400 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 24 | Phase 1 | Portugal |
| 278 | EUCTR2004-000817-20-IT (EUCTR) | 06/04/2005 | 13/04/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 279 | EUCTR2004-002844-93-ES (EUCTR) | 01/04/2005 | 04/11/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 280 | EUCTR2004-001593-10-GB (EUCTR) | 21/03/2005 | 25/08/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: SARIZOTAN Product Code: EMD128130 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 281 | EUCTR2004-002844-93-EE (EUCTR) | 08/03/2005 | 07/03/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 282 | NCT00203957 (ClinicalTrials.gov) | March 2005 | 13/9/2005 | Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy | Parkinson's Disease | Drug: Istradefylline | University of Chicago | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 3 | United States |
| 283 | EUCTR2004-002844-93-LT (EUCTR) | 08/02/2005 | 03/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 284 | EUCTR2004-001594-25-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 285 | EUCTR2004-000817-20-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Lithuania;Austria;Latvia;Italy | |||
| 286 | EUCTR2004-002844-93-GB (EUCTR) | 01/02/2005 | 23/02/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain | ||||
| 287 | EUCTR2004-002844-93-LV (EUCTR) | 28/01/2005 | 31/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
| 288 | EUCTR2004-001594-25-FI (EUCTR) | 30/12/2004 | 26/10/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain | ||
| 289 | EUCTR2004-002609-66-IT (EUCTR) | 21/12/2004 | 03/03/2006 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 290 | EUCTR2004-000817-20-ES (EUCTR) | 10/12/2004 | 04/05/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 291 | EUCTR2004-000835-27-IT (EUCTR) | 03/12/2004 | 21/07/2005 | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 292 | EUCTR2004-000833-12-IT (EUCTR) | 02/12/2004 | 15/03/2005 | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 293 | EUCTR2004-001593-10-IT (EUCTR) | 02/12/2004 | 03/01/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan hydrochloride Product Code: EMD 128130 INN or Proposed INN: Sarizotan hydrochloride | MERCK S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom;Italy | |||
| 294 | EUCTR2004-000833-12-ES (EUCTR) | 02/12/2004 | 23/11/2004 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Spain;Italy | ||
| 295 | NCT00643045 (ClinicalTrials.gov) | December 2004 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 269 | Phase 3 | NULL |
| 296 | EUCTR2004-001594-25-ES (EUCTR) | 24/11/2004 | 02/11/2004 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan Product Code: EMD 128130 INN or Proposed INN: Sarizotan Hydrochloride | MERCK KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 297 | EUCTR2004-000817-20-GB (EUCTR) | 08/11/2004 | 11/02/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | ||
| 298 | NCT03091868 (ClinicalTrials.gov) | November 3, 2004 | 21/3/2017 | Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | Portugal |
| 299 | NCT00199394 (ClinicalTrials.gov) | November 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin UK, Ltd. | NULL | Completed | 30 Years | N/A | Both | 405 | Phase 3 | United Kingdom |
| 300 | EUCTR2004-000817-20-LV (EUCTR) | 22/10/2004 | 27/10/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 301 | NCT00199368 (ClinicalTrials.gov) | October 2004 | 12/9/2005 | An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018 | A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline ( KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | Kyowa Hakko Kirin UK, Ltd. | Completed | 30 Years | N/A | Both | 1100 | Phase 3 | United States |
| 302 | NCT00105508 (ClinicalTrials.gov) | September 30, 2004 | 15/3/2005 | Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan;Drug: Placebo | EMD Serono | NULL | Completed | 30 Years | N/A | All | 506 | Phase 3 | United States |
| 303 | EUCTR2004-000817-20-LT (EUCTR) | 16/09/2004 | 07/01/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 304 | EUCTR2004-003355-39-AT (EUCTR) | 14/09/2004 | 08/10/2004 | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | Dementia associated with Parkinson's disease | Trade Name: Aricept 5 mg-Filmtabletten Product Name: Aricept 5mg-Filmtabletten | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 468 | Austria | |||
| 305 | NCT00105521 (ClinicalTrials.gov) | September 2004 | 15/3/2005 | Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HC1 | EMD Serono | NULL | Completed | 30 Years | N/A | All | 594 | Phase 3 | United States |
| 306 | NCT00199420 (ClinicalTrials.gov) | July 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 580 | Phase 3 | United States |
| 307 | NCT00199407 (ClinicalTrials.gov) | June 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 230 | Phase 3 | United States |
| 308 | NCT03091543 (ClinicalTrials.gov) | May 4, 2004 | 21/3/2017 | Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg | Parkinson Disease | Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Portugal |
| 309 | NCT00673088 (ClinicalTrials.gov) | February 2004 | 5/5/2008 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions | Parkinson's Disease;Restless Leg Syndrome | Drug: Ropinirole Hydrochloride | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 30 | N/A | NULL |
| 310 | NCT00674310 (ClinicalTrials.gov) | February 2004 | 5/5/2008 | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions | Parkinson's Disease;Restless Leg Syndrome | Drug: Ropinirole Hydrochloride | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 29 | N/A | NULL |
| 311 | NCT00234676 (ClinicalTrials.gov) | October 2003 | 5/10/2005 | POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease | A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease | Parkinson's Disease | Drug: Premarin ® | The Parkinson Study Group | Wyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman Foundation | Completed | N/A | 75 Years | Female | 23 | Phase 2 | United States |
| 312 | NCT00160576 (ClinicalTrials.gov) | July 2003 | 8/9/2005 | Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias | A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease | Idiopathic Parkinson Disease | Drug: Levetiracetam | UCB Pharma | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | NULL |
| 313 | NCT00148512 (ClinicalTrials.gov) | March 2003 | 7/9/2005 | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS) | Parkinson Disease | Drug: 1. Tesofensine (NS 2330) | Boehringer Ingelheim | NULL | Completed | 42 Years | 80 Years | Both | 254 | Phase 2 | Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador |
| 314 | NCT00451815 (ClinicalTrials.gov) | January 2003 | 31/1/2006 | BIIB014 Phase 2a Monotherapy | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson’s Disease | Parkinson's Disease | Drug: active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.;Drug: placebo | Biogen Idec | NULL | Withdrawn | 30 Years | 78 Years | Both | Phase 2 | NULL | |
| 315 | NCT00456586 (ClinicalTrials.gov) | April 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: KW-6002 (istradefylline) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States |
| 316 | NCT00456794 (ClinicalTrials.gov) | March 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 325 | Phase 2 | United States |
| 317 | NCT00203177 (ClinicalTrials.gov) | October 2001 | 13/9/2005 | Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy. | A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: rasagiline mesylate;Drug: rasagiline mesylate 1.0 mg | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 254 | Phase 3 | United States;Canada |
| 318 | NCT02763839 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet 25/100 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 19 | Phase 1 | Portugal |
| 319 | NCT02763852 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 18 | Phase 1 | Portugal |
| 320 | NCT00145171 (ClinicalTrials.gov) | February 2001 | 2/9/2005 | A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 3 | NULL |
| 321 | NCT00203034 (ClinicalTrials.gov) | May 2000 | 13/9/2005 | Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: rasagiline mesylate;Drug: 1.0 mg rasagiline mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 472 | Phase 3 | United States |
| 322 | NCT00274131 (ClinicalTrials.gov) | December 1998 | 9/1/2006 | Long-term Administration Study of SND 919 Tablets in Parkinson's Disease | Long-term Administration Study of SND 919 Tablets in Parkinson's Disease | Parkinson Disease | Drug: Pramipexole 0.125 mg tablets;Drug: Pramipexole 0.5 mg tablets | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 170 | Phase 3 | NULL |
| 323 | EUCTR2009-014341-84-DE (EUCTR) | 07/10/2009 | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | idiopathic Parkinson's disease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 2mg/24h(10cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 4mg/24h (20cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 6mg/24h (30cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 8mg/24h (40cm2) INN or Proposed INN: rotigotine | Schwarz Pharma Deutschland GmbH, UCB Group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | |||||
| 324 | EUCTR2008-004447-11-DE (EUCTR) | 17/10/2008 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;Italy;United Kingdom | |||
| 325 | JPRN-JapicCTI-111699 | 22/11/2011 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects with Advanced Parkinson's Disease | Advanced Parkinson's disease | Intervention name : ABT-SLV187 Dosage And administration of the intervention : Usually 2-6 ml/hour (40-120 mg levodopa/hour), dose will be individually optimized for each subject based on the subject's symptoms Control intervention name : null | Abbott Japan Co., Ltd. | NULL | 30 | BOTH | 8 | Phase 2 | NULL |