BENSERAZIDE ( DrugBank: Benserazide )


1 disease
IDDisease name (Link within this page)Number of trials
6Parkinson disease31

6. Parkinson disease


Clinical trials : 2,307 Drugs : 2,007 - (DrugBank : 349) / Drug target genes : 188 - Drug target pathways : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002754-24-DE
(EUCTR)
19/01/202214/06/2021Clinical 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Portugal;Spain;Germany;United Kingdom;Italy
2EUCTR2020-002754-24-IT
(EUCTR)
09/09/202130/08/2021Clinical 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Portugal;Spain;Germany;United Kingdom;Italy
3EUCTR2020-002754-24-ES
(EUCTR)
06/07/202109/06/2021Clinical 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Portugal;Spain;Germany;United Kingdom;Italy
4ChiCTR2000039201
2020-11-152020-10-21Pharmacology of levodopa/carbidopa versus levodopa/benserazide in patients with parkinson's diseasePharmacology of levodopa/carbidopa versus levodopa/benserazide in patients with parkinson's disease Parkinson's diseaseA:phase I: levodopa/carbidopa; phase II: levodopa/benserazide ;B:phase I: levodopa/benserazide; phase II: levodopa/carbidopa;The Affiliated Brain Hospital of Nanjing Medical University (Nanjing Brain Hospital)NULLRecruiting3085BothA:10;B:10;Phase 4China
5EUCTR2017-002426-20-FR
(EUCTR)
05/04/201926/11/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA 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 SpANULLNot RecruitingFemale: yes
Male: yes
177Phase 4France;Spain;Austria
6EUCTR2017-002426-20-IT
(EUCTR)
21/02/201907/10/2020Effect of Safinamide on Parkinson's Disease Related Chronic PainA 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 SPANULLNot RecruitingFemale: yes
Male: yes
177Phase 4Germany;Italy;France;Spain;Austria
7EUCTR2017-002426-20-AT
(EUCTR)
22/01/201903/12/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA 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 SpANULLNot RecruitingFemale: yes
Male: yes
105Phase 4Spain;Austria
8EUCTR2017-002426-20-ES
(EUCTR)
19/10/201820/08/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA 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 SpANULLNot RecruitingFemale: yes
Male: yes
177Phase 4France;Spain;Austria;Italy
9EUCTR2015-001523-24-FR
(EUCTR)
25/03/201620/04/2016Evaluation of the pain relief of prolonged-release oxycodone and of L-Dopa, versus placebo, in Parkinson's disease.Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA Central neuropathic pain in Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: oxycontin LP 5mg
Product Name: Oxycontin LP 5mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: oxycontin LP 10mg
Product Name: Oxycontin LP 10mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: oxycontin LP 20mg
Product Name: Oxycontin LP 20mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: Modopar 125
Product Name: Modopar 125
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: BENSERAZIDE
Trade Name: Modopar 62,5
Product Name: Modopar 62,5
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
UHToulouseNULLNot RecruitingFemale: yes
Male: yes
75Phase 2;Phase 3France
10NCT02769793
(ClinicalTrials.gov)
June 20159/5/2016Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ONEfficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over TrialParkinson DiseaseDrug: Levodopa dispersible;Drug: LevodopaSeoul National University HospitalSMG-SNU Boramae Medical Center;Samsung Medical CenterCompleted31 Years80 YearsAll40Phase 4Korea, Republic of
11NCT02741947
(ClinicalTrials.gov)
April 201431/3/2016Levodopa Benserazide Generic Formulation Versus the OriginatorClinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)Parkinson DiseaseDrug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva ItaliaIRCCS San RaffaeleAgenzia Italiana del FarmacoCompleted30 Years75 YearsBoth44Phase 4Italy
12EUCTR2012-001245-40-IT
(EUCTR)
05/06/201317/05/2013CLINICAL 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
NULLNot RecruitingFemale: yes
Male: yes
Italy
13NCT01227655
(ClinicalTrials.gov)
March 201122/10/2010Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.Parkinson's DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll427Phase 3Portugal
14NCT01568073
(ClinicalTrials.gov)
March 201129/3/2012Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off PhenomenonEfficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical StudyParkinson's DiseaseDrug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll600Phase 3Portugal;Austria
15EUCTR2010-022363-35-DE
(EUCTR)
18/02/201119/10/2010Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Madopar LT
Product Name: Levodopa / Benserazid
Product Code: LD / BE
INN or Proposed INN: LEVODOPA
Other descriptive name: -
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE
Other descriptive name: -
Trade Name: Neupro
Product Name: Rotigotin
Product Code: RO
INN or Proposed INN: ROTIGOTINE
Other descriptive name: -
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
16EUCTR2010-019354-40-AT
(EUCTR)
26/05/201026/04/2010Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem ParkinsonsyndromÜberprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Madopar
INN or Proposed INN: LEVODOPA
INN or Proposed INN: BENSERAZIDE
Universitätsklinik für Neurologie InnsbruckNULLNot RecruitingFemale: yes
Male: yes
15Austria
17NCT02169414
(ClinicalTrials.gov)
February 201024/1/2012Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa PharmacokineticsEffect 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 SubjectsParkinson'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 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll74Phase 1France
18NCT01568047
(ClinicalTrials.gov)
February 201029/3/2012Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) PatientsMulticentre, 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 DiseaseDrug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 YearsN/AAll40Phase 2Romania;Ukraine
19EUCTR2009-012897-12-RO
(EUCTR)
08/12/200930/03/2015A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitorA double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor Parkinson’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852
Product Name: BIA 9-1067
Product Code: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Restex Tabletten
INN or Proposed INN: LEVODOPA
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE
BIAL-Portela & Ca, SANULLNot RecruitingFemale: yes
Male: yes
32Romania
20NCT01533116
(ClinicalTrials.gov)
March 200924/1/2012Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/BenserazideEffect 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 SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazideBial - Portela C S.A.NULLCompleted25 Years45 YearsAll52Phase 1Canada
21NCT02169466
(ClinicalTrials.gov)
January 200920/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/BenserazidePharmacokinetic-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 SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBSBial - Portela C S.A.NULLCompleted18 Years45 YearsMale22Phase 1Portugal
22NCT02169895
(ClinicalTrials.gov)
September 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/BenserazidePharmacokinetic-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 SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa®Bial - Portela C S.A.NULLCompleted25 Years45 YearsMale16Phase 1Canada
23ChiCTR-TRC-07000027
2007-11-012007-11-09A randomized controlled clinical study of Pramipexole for Parkinson's diseaseA randomized controlled clinical study of Pramipexole for Parkinson's disease Primary Parkinson's diseaseGroup 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 UniversityNULLCompleted3080BothGroup 1:45;Group 3:45;Group 2:45;China
24EUCTR2006-001793-24-PT
(EUCTR)
07/11/200631/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Trade Name: COMTAN®
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
25NCT03103399
(ClinicalTrials.gov)
September 26, 200628/3/2017Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff PhenomenonA Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/BenserazideParkinson DiseaseDrug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: PlaceboBial - Portela C S.A.NULLCompleted30 Years80 YearsAll254Phase 2NULL
26EUCTR2006-001793-24-AT
(EUCTR)
31/07/200624/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
27NCT03097211
(ClinicalTrials.gov)
July 17, 200627/3/2017Effect 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 mgA 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 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: NebicaponeBial - Portela C S.A.NULLCompleted18 Years45 YearsAll38Phase 1Portugal
28NCT03094156
(ClinicalTrials.gov)
April 26, 200623/3/2017Effect of BIA 6-512 at Steady-state on the Levodopa PharmacokineticsA 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 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan®Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll39Phase 1Portugal
29NCT02778594
(ClinicalTrials.gov)
September 200518/5/2016Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/BenserazidePharmacokinetic-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 VolunteersParkinson's Disease (PD)Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsBoth17Phase 1Portugal
30NCT03091543
(ClinicalTrials.gov)
May 4, 200421/3/2017Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa PharmacokineticsA 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 mgParkinson DiseaseDrug: 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 doseBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Portugal
31NCT02763852
(ClinicalTrials.gov)
April 20014/5/2016Pharmacokinetic-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 VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth18Phase 1Portugal