6. パーキンソン病 Parkinson disease Clinical trials / Disease details


臨床試験数 : 2,298 薬物数 : 2,218 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202

  
239 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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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
2NCT05094050
(ClinicalTrials.gov)
January 18, 202220/10/2021Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's DiseaseParkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease PatientsParkinson's DiseaseDrug: ABBV-951AbbVieNULLRecruiting30 YearsN/AAll12Phase 1United States
3NCT04952194
(ClinicalTrials.gov)
January 1, 20223/6/2021Clinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseClinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseParkinson DiseaseDrug: Stalevo;Drug: Carbidopa and Levodopa Controlled Release TabletsSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLNot yet recruiting30 Years70 YearsAll180Phase 4NULL
4EUCTR2019-004235-23-SE
(EUCTR)
13/11/202124/08/2021Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
5NCT05083260
(ClinicalTrials.gov)
November 202123/9/2021NE3107 Activity and Safety in Patients With Parkinson's Disease Using LevodopaA Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107Parkinson DiseaseDrug: NE3107;Drug: placeboBioVie Inc.NULLNot yet recruiting30 Years75 YearsAll40Phase 1/Phase 2NULL
6NCT05128175
(ClinicalTrials.gov)
October 29, 202127/10/2021Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed ConditionsAn Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed ConditionsParkinson DiseaseDrug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsShanghai WD Pharmaceutical Co., Ltd.NULLRecruiting18 Years45 YearsAll15Phase 1India
7NCT05036473
(ClinicalTrials.gov)
October 12, 202110/8/2021A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's DiseaseA Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's DiseaseParkinson DiseaseDrug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets;Drug: PlaceboShanghai WD Pharmaceutical Co., Ltd.NULLRecruiting30 Years75 YearsAll40Phase 2China
8EUCTR2020-002754-24-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
9EUCTR2020-003372-41-ES
(EUCTR)
27/07/202109/06/2021Investigating the DopaFuse® Delivery System in Parkinson’s Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body.Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL Motor symptoms in 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: DopaFuse Delivery System
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
SynAgile CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1;Phase 2Spain;Luxembourg;Italy
10EUCTR2020-002754-24-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
11EUCTR2019-004235-23-DE
(EUCTR)
19/05/202125/02/2021Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan
12EUCTR2020-003372-41-IT
(EUCTR)
27/01/202115/06/2021Investigating the DopaFuse® Delivery System in Parkinson's Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body.Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse® Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL Motor symptoms in 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: DopaFuse Delivery System
Product Code: [N04BA]
INN or Proposed INN: LEVODOPA
Other descriptive name: Levodopa
INN or Proposed INN: CARBIDOPA
Other descriptive name: Carbidopa
SynAgile CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Spain;Luxembourg;Italy
13NCT04590612
(ClinicalTrials.gov)
January 202117/9/2020Improving Quality of Life in Early Parkinson's DiseaseThe Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease PatientsParkinson Disease;DepressionDrug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: CitalopramWestern University, CanadaNULLNot yet recruiting50 Years80 YearsAll30N/ANULL
14EUCTR2019-004235-23-DK
(EUCTR)
18/11/202022/06/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Denmark;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
15EUCTR2019-004235-23-NL
(EUCTR)
09/11/202026/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
16NCT04380142
(ClinicalTrials.gov)
October 19, 20206/5/2020Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's DiseaseA Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease PatientsParkinson's Disease (PD)Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951AbbVieNULLCompleted30 YearsN/AAll174Phase 3United States;Australia
17NCT04591535
(ClinicalTrials.gov)
September 28, 202011/9/2020PK Study of WD-1603 in Healthy SubjectsAn Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed ConditionsParkinson DiseaseDrug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
18EUCTR2019-004235-23-GB
(EUCTR)
15/09/202028/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects 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: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Japan;United Kingdom
19NCT04513340
(ClinicalTrials.gov)
August 13, 202012/8/2020WD-1603 PK Study Under Fasting and Fed Conditions in Healthy SubjectsAN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONSParkinson DiseaseDrug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
20JPRN-UMIN000040889
2020/06/2424/06/2020Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's diseaseComparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease Parkinson's diseaseLevodopa-carbidopa continuous infusion gel (LCIG) therapyFujita Health University School of MedicineDepartment of GastroenterologyNULLRecruiting20years-oldNot applicableMale and Female200Phase 4Japan
21EUCTR2018-004156-37-PT
(EUCTR)
16/06/202009/12/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD/CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of
22EUCTR2018-004156-37-NL
(EUCTR)
14/06/202013/01/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden
23EUCTR2018-004156-37-SE
(EUCTR)
18/05/202010/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
24EUCTR2018-002144-85-DE
(EUCTR)
07/05/202006/06/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Japan
25EUCTR2018-004156-37-IT
(EUCTR)
04/05/202017/06/2021A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations (BouNDless) - BouNDless 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: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
Product Code: [NA]
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: [ND0612]
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
NEURODERM LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
26EUCTR2018-004156-37-SK
(EUCTR)
30/04/202013/02/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: Levodopa/Carbidopa Solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden
27EUCTR2018-004156-37-BE
(EUCTR)
27/04/202003/03/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden
28EUCTR2018-002233-37-PL
(EUCTR)
23/04/202024/01/2020Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
29EUCTR2020-000686-16-NL
(EUCTR)
26/03/202009/03/2020Validation of finger tapping in PD patientsRandomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. 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: SINEMET 125
Product Name: SINEMET
Product Code: RVG 08740
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopamonohydraat
Other descriptive name: CARBIDOPA MONOHYDRATE
Centre for Human Drug ResearchNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Netherlands
30EUCTR2018-004156-37-AT
(EUCTR)
02/03/202005/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden
31NCT04821830
(ClinicalTrials.gov)
February 12, 202010/3/2021Vigor and the LDR in Parkinson DiseaseVigor and the LDR in Parkinson DiseaseParkinson DiseaseDrug: carbidopa/levodopa, as prescribed by treating physicianUniversity of MichiganNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting45 Years90 YearsAll40United States
32EUCTR2018-004156-37-ES
(EUCTR)
11/02/202006/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
33EUCTR2018-002234-21-GB
(EUCTR)
05/02/202004/07/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
34NCT04246437
(ClinicalTrials.gov)
February 4, 202025/1/2020[18F]F-DOPA Imaging in Patients With Autonomic Failure[18F]F-DOPA Imaging in Patients With Autonomic FailureAutonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy BodiesDrug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral doseDaniel ClaassenNULLRecruiting18 YearsN/AAll40Phase 1United States
35EUCTR2018-004156-37-GB
(EUCTR)
14/01/202013/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
36EUCTR2018-004156-37-HU
(EUCTR)
19/12/201918/10/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
37EUCTR2018-004156-37-CZ
(EUCTR)
26/11/201926/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden
38EUCTR2018-002233-37-GB
(EUCTR)
11/10/201914/02/2019Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
39EUCTR2018-002234-21-DE
(EUCTR)
23/09/201916/05/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
40EUCTR2018-002144-85-NL
(EUCTR)
11/09/201927/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan
41NCT04006210
(ClinicalTrials.gov)
August 27, 201930/6/2019A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless).A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)Parkinson's DiseaseCombination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mgNeuroDerm Ltd.NULLRecruiting30 Years80 YearsAll380Phase 3United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom
42EUCTR2018-002234-21-ES
(EUCTR)
21/08/201911/06/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
43EUCTR2018-002144-85-BE
(EUCTR)
20/08/201924/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan
44EUCTR2018-002144-85-GB
(EUCTR)
29/07/201913/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom
45EUCTR2018-002144-85-ES
(EUCTR)
11/07/201912/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan
46EUCTR2018-002144-85-DK
(EUCTR)
08/07/201914/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde 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 Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan
47EUCTR2018-002144-85-IT
(EUCTR)
21/06/201915/06/2021Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ABBV-951
Product Code: [ABBV-951]
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan;Italy
48EUCTR2018-002234-21-CZ
(EUCTR)
14/06/201930/05/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia
49EUCTR2018-002233-37-IT
(EUCTR)
03/05/201907/01/2021Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. - NA Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: [IPX203]
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: [IR CD-LD]
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy
50EUCTR2018-002233-37-DE
(EUCTR)
17/04/201908/01/2019Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
51EUCTR2018-002233-37-CZ
(EUCTR)
18/03/201911/12/2018Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy
52NCT03887884
(ClinicalTrials.gov)
March 5, 20191/3/2019Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301;Drug: SinemetAcorda TherapeuticsNULLCompleted30 Years85 YearsAll23Phase 1United States
53NCT03670953
(ClinicalTrials.gov)
November 6, 201812/9/2018A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor FluctuationsA Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor FluctuationsParkinson's Disease (Disorder)Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placeboImpax Laboratories, LLCNULLCompleted40 YearsN/AAll631Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
54EUCTR2016-002033-30-NL
(EUCTR)
31/10/201815/11/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
55EUCTR2018-001209-95-IT
(EUCTR)
05/07/201803/08/2021An 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 diseaseAn 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 LTDNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Spain;Italy
56NCT03576638
(ClinicalTrials.gov)
July 201825/6/2018Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease PatientsAn Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release TabletIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll12Phase 2NULL
57EUCTR2017-002780-17-ES
(EUCTR)
21/05/201812/02/2018Study 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;United States;Spain;Austria;Netherlands;Italy
58EUCTR2017-002780-17-FR
(EUCTR)
26/04/201827/02/2018-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.NULLNot 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): noUnited States;France;Spain;Austria;Netherlands;Italy
59EUCTR2017-002780-17-IT
(EUCTR)
10/04/201804/11/2020study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusionA 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
60NCT03496870
(ClinicalTrials.gov)
February 8, 20181/3/2018A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Carbidopa LevodopaNeurocrine BiosciencesNULLCompleted18 Years85 YearsAll16Phase 1United States
61EUCTR2016-001403-23-HU
(EUCTR)
23/01/201822/01/201812-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
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: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
62EUCTR2016-002033-30-GB
(EUCTR)
27/11/201705/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
63EUCTR2016-002033-30-HU
(EUCTR)
08/11/201719/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany
64EUCTR2014-004865-26-GR
(EUCTR)
01/08/201725/04/201726-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
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: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
65EUCTR2017-000262-30-IT
(EUCTR)
10/07/201704/11/2020Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuationsEfficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA Parkinson's Desease (PD)
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]
Product Name: EXN-44(LEVODOPA)
Product Code: EXN-44
Trade Name: Sinemet
Product Name: EXN-32 (CARBIDOPA E LEVODOPA)
Product Code: EXN-32
DR. REDDY’S LABORATORIES LIMITEDNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Italy
66EUCTR2015-005814-31-BE
(EUCTR)
06/07/201705/05/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
67EUCTR2015-005814-31-ES
(EUCTR)
22/06/201721/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
68EUCTR2015-005814-31-HU
(EUCTR)
14/06/201720/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany
69EUCTR2015-005814-31-PL
(EUCTR)
25/05/201714/02/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy;France
70EUCTR2015-004507-23-FI
(EUCTR)
08/05/201730/03/2017Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
71NCT03140956
(ClinicalTrials.gov)
April 19, 201712/4/2017Pharmacokinetic of Levodopa Study in Healthy MalesPharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male SubjectsParkinson DiseaseDrug: Levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
72NCT03115827
(ClinicalTrials.gov)
April 18, 20179/3/2017Norepinephrine-targeted Therapy for Action Control in Parkinson DiseaseNorepinephrine-targeted Therapy for Action Control in Parkinson DiseaseParkinson DiseaseDrug: Droxidopa;Drug: CarbidopaVanderbilt University Medical CenterH. Lundbeck A/S;American Academy of NeurologyCompleted18 YearsN/AAll15Phase 4United States
73EUCTR2016-001403-23-GR
(EUCTR)
31/03/201714/10/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
74EUCTR2015-003513-24-SK
(EUCTR)
14/03/201704/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
75EUCTR2015-005814-31-CZ
(EUCTR)
03/03/201701/12/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
76EUCTR2015-004507-23-HU
(EUCTR)
24/02/201704/01/2017Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
77EUCTR2016-001403-23-FI
(EUCTR)
22/02/201731/08/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
78NCT02799381
(ClinicalTrials.gov)
February 9, 201710/6/2016A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)Parkinson's Disease (PD)Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tubeAbbVieNULLCompleted30 YearsN/AAll63Phase 3United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
79EUCTR2015-005814-31-DE
(EUCTR)
07/02/201724/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
80EUCTR2016-002033-30-BE
(EUCTR)
19/12/201621/11/2016A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
81EUCTR2016-001403-23-SK
(EUCTR)
29/11/201607/09/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
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: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;European Union;Slovakia;Greece;Finland;Spain
82EUCTR2016-002033-30-FR
(EUCTR)
29/11/201612/01/2017A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 19.1;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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
83EUCTR2016-001403-23-ES
(EUCTR)
14/11/201615/11/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
84EUCTR2016-002033-30-ES
(EUCTR)
03/11/201625/08/2016A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden
85EUCTR2015-005078-39-DE
(EUCTR)
21/09/201602/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced 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]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
86EUCTR2016-001403-23-IT
(EUCTR)
13/09/201606/09/202112-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
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: Duodopa
Product Name: na
Product Code: [na]
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy
87EUCTR2015-003513-24-DE
(EUCTR)
08/09/201615/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
88EUCTR2015-005814-31-AT
(EUCTR)
29/08/201611/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
89NCT02615873
(ClinicalTrials.gov)
July 201623/11/2015A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004An 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 004Parkinson's DiseaseDrug: Accordion Pill™ Carbidopa/LevodopaIntec Pharma Ltd.NULLUnknown status30 Years100 YearsAll460Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom
90EUCTR2015-003513-24-BG
(EUCTR)
27/06/201626/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
91EUCTR2015-005814-31-IT
(EUCTR)
23/06/201614/01/2021Not availableA multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Soluzione di levodopa/carbidopa
Product Code: ND0612
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA (LD)
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA (CD)
NEURODERM LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
92EUCTR2015-003513-24-IT
(EUCTR)
23/06/201605/11/2020OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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 LTDNULLNot RecruitingFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
93EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
94EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
95EUCTR2015-005078-39-IT
(EUCTR)
08/06/201619/01/2021NAA multicenter, parallel-group, rater-blinded, randomized clinical studyinvestigating the efficacy, safety, tolerability and pharmacokinetics of2 dosing regimens of ND0612H, a solution of levodopa/carbidopadelivered via a pump system as a continuous subcutaneous infusion insubjects with advanced Parkinson's disease - NA advanced 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: soluzione di levodopa/carbidopa
Product Code: ND0612
INN or Proposed INN: LEVODOPA
Other descriptive name: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
NEURODERM LTD.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
96NCT02812394
(ClinicalTrials.gov)
June 201622/6/2016A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) TabletsA Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) TabletsParkinson DiseaseDrug: CVT-301 (Dose Level 1);Drug: CVT-301 (Dose Level 2);Drug: Sinemet®Acorda TherapeuticsNULLCompleted25 Years65 YearsBoth24Phase 1United States
97EUCTR2015-005078-39-AT
(EUCTR)
30/05/201609/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced 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: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
98EUCTR2015-003513-24-HU
(EUCTR)
24/05/201602/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
99EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
100EUCTR2015-003513-24-ES
(EUCTR)
18/05/201618/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
101EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
102EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
103EUCTR2015-003513-24-GB
(EUCTR)
28/04/201604/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
104EUCTR2015-004507-23-DE
(EUCTR)
25/04/201613/01/2016Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
105EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
106EUCTR2015-004507-23-LV
(EUCTR)
15/03/201613/01/2016Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Finland;Germany;Latvia
107NCT02605434
(ClinicalTrials.gov)
March 20165/11/2015A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's PatientsPhase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's PatientsParkinson's DiseaseDrug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- SinemetIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll420Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary
108EUCTR2014-004865-26-IT
(EUCTR)
21/09/201529/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88European Union;Canada;Spain;Australia;Germany;Italy;Sweden
109NCT02549092
(ClinicalTrials.gov)
September 9, 201511/9/2015A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS StudyAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLActive, not recruiting30 Years99 YearsAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
110EUCTR2014-004865-26-DE
(EUCTR)
27/08/201522/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3European Union;Canada;Spain;Australia;Germany;Italy;Sweden
111EUCTR2014-004865-26-SE
(EUCTR)
05/08/201525/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
112NCT02554734
(ClinicalTrials.gov)
August 201510/6/2015Pharmacokinetic Study in Healthy VolunteersPharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and FemalesParkinson's DiseaseDrug: levodopa, carbidopa, ODM-104;Drug: levodopa, carbidopa, entacaponeOrion Corporation, Orion PharmaNULLCompleted18 Years65 YearsBoth15Phase 1Finland
113EUCTR2014-004865-26-ES
(EUCTR)
19/06/201515/06/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEuropean Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
114NCT02448914
(ClinicalTrials.gov)
May 201512/5/2015A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD PatientsA Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s DiseaseParkinson's DiseaseDrug: TRIGEL;Drug: DuodopaLobSor Pharmaceuticals ABTFS Trial Form SupportCompleted30 YearsN/AAll11Phase 1Sweden
115EUCTR2014-004501-32-NL
(EUCTR)
11/12/201403/12/2014Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatmentsInfusion 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 gelAcademic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
116NCT02480803
(ClinicalTrials.gov)
December 20144/5/2015INfusion VErsus STimulation in Parkinson's DiseaseTreatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulationParkinson's DiseaseDrug: Continuous intrajejunal infusion of levodopa-carbidopa;Device: deep brain stimulationAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 YearsN/AAll66Phase 4Netherlands
117NCT02312232
(ClinicalTrials.gov)
November 20142/12/2014Pharmacokinetic Study in Healthy MalesPharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy MalesParkinson's DiseaseDrug: levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
118NCT02096601
(ClinicalTrials.gov)
August 201418/3/2014A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease PatientsA Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LDParkinson's DiseaseDrug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopaNeuroDerm Ltd.Michael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll16Phase 1/Phase 2United States;Israel
119NCT01883505
(ClinicalTrials.gov)
December 20139/6/2013A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612Parkinson's DiseaseDrug: Levodopa and carbidopa;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth30Phase 2Israel
120NCT01960842
(ClinicalTrials.gov)
October 20139/10/2013A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVieNULLCompleted30 YearsN/AAll31Phase 3Japan;Korea, Republic of;Taiwan
121NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's DiseaseAn Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
122NCT01725802
(ClinicalTrials.gov)
December 20124/11/2012A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsA Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsParkinson's DiseaseDrug: levodopa and carbidopa solution for SC administration;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth8Phase 1/Phase 2Israel
123NCT00947037
(ClinicalTrials.gov)
August 201224/7/2009Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension StudyAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease SubjectsParkinson's DiseaseDrug: AP-CD/LDIntec Pharma Ltd.NULLWithdrawn30 Years95 YearsBoth0Phase 2Israel
124NCT01617135
(ClinicalTrials.gov)
May 20127/5/2012Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off EpisodesA Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa)Acorda TherapeuticsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll25Phase 2Israel;Serbia;United Kingdom
125EUCTR2012-000181-37-GB
(EUCTR)
25/04/201227/02/2012A study investigating the safety of CVT-301 in patients with Parkinson's DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Israel;United Kingdom
126NCT01515410
(ClinicalTrials.gov)
January 201211/1/2012Study in Advanced Parkinson's Disease Patients With Predictable Motor FluctuationsA Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor FluctuationsParkinson's Disease;Motor FluctuationsDrug: DM-1992;Drug: Sinemet IRDepomedNULLCompleted30 YearsN/AAll34Phase 2United States
127NCT01411137
(ClinicalTrials.gov)
August 20114/8/2011Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety StudyAn Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PDParkinson's DiseaseDrug: IPX066Impax Laboratories, LLCMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll43Phase 3United States
128EUCTR2010-022200-46-LV
(EUCTR)
21/06/201101/04/2011Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease.Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC Parkinson's disease
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]
Product Name: ODM-101
Product Code: 75
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
Product Name: ODM-101
Product Code: 100
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
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
129NCT01528592
(ClinicalTrials.gov)
June 201131/1/2012PharmacoMRI of Parkinson DiseaseA Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's DiseaseParkinson's DiseaseDrug: Carbidopa-LevodopaNorthwestern UniversityNULLCompleted30 YearsN/AAll18N/AUnited States
130EUCTR2010-022200-46-FI
(EUCTR)
13/05/201123/03/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 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 motor fluctuations. - PARPOC Parkinson's disease
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: ODM-101
Product Code: 75
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
Product Name: ODM-101
Product Code: 100
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
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Germany;Latvia;Lithuania
131EUCTR2010-022200-46-LT
(EUCTR)
09/05/201105/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 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 motor fluctuations. - PARPOC Parkinson's disease
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: ODM-101
Product Code: 75
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
Product Name: ODM-101
Product Code: 100
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
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
132NCT01766258
(ClinicalTrials.gov)
May 201122/11/2012Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor FluctuationsEfficacy and Safety of ODM-101 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 Motor FluctuationsParkinson's DiseaseDrug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: StalevoOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth117Phase 2NULL
133NCT01227655
(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
134NCT01568073
(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
135EUCTR2008-001329-33-GB
(EUCTR)
24/02/201115/03/2010Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-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 IncNULLNot 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): noPortugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom
136NCT01296464
(ClinicalTrials.gov)
February 201114/2/2011Comparing Different Levodopa/Carbidopa/Entacapone Treatment RegimensDuration 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 SymptomsParkinson's DiseaseDrug: CarbidopaOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth27Phase 2Finland;Sweden
137EUCTR2010-022915-21-SE
(EUCTR)
12/01/201118/11/2010Duration 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 - PARTESTDuration 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
138EUCTR2010-022915-21-FI
(EUCTR)
10/01/201111/11/2010Duration 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 - PARTESTDuration 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
139NCT01229332
(ClinicalTrials.gov)
January 20113/10/2010A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease PatientsA Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: Saline;Drug: CarbidopaNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth24Phase 1/Phase 2Israel
140EUCTR2009-017238-39-DE
(EUCTR)
16/09/201028/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
96Phase 3France;Belgium;Germany;Italy
141EUCTR2009-017238-39-FR
(EUCTR)
15/09/201009/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
142EUCTR2009-017238-39-BE
(EUCTR)
27/08/201014/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
143EUCTR2009-017182-38-ES
(EUCTR)
26/07/201025/05/2010Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. Enfermedad de Parkinson idiopática (parálisis agitante)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Estonia;Poland;Spain;Lithuania;Germany;Latvia
144EUCTR2009-017182-38-LT
(EUCTR)
10/07/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
145EUCTR2009-017182-38-DE
(EUCTR)
09/07/201007/05/2010An 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. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLNot RecruitingFemale: yes
Male: yes
500Estonia;Spain;Poland;Lithuania;Latvia;Germany
146EUCTR2009-017182-38-PL
(EUCTR)
07/07/201020/05/2010An 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. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
147NCT01171313
(ClinicalTrials.gov)
July 201026/7/2010A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease SubjectsA Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: XP21279 and carbidopa (experimental);Drug: Sinemet (comparator);Drug: Placebo for XP21279 and carbidopa;Drug: Placebo for SinemetXenoPort, Inc.NULLCompleted30 Years80 YearsAll35Phase 2United States
148EUCTR2009-017238-39-IT
(EUCTR)
21/06/201013/07/2010A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - NDA Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10061536
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA LEVODOPA
Trade Name: NACOM 100
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: COMTAN
INN or Proposed INN: Entacapone
IMPAX LABORATORIES, INC.NULLNot RecruitingFemale: yes
Male: yes
56Germany;France;Italy
149EUCTR2009-017182-38-LV
(EUCTR)
11/06/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
150EUCTR2009-017182-38-EE
(EUCTR)
14/05/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
151NCT01130493
(ClinicalTrials.gov)
May 201024/5/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: CLEImpax Laboratories, LLCNULLCompleted30 YearsN/AAll110Phase 3United States;France;Germany;Italy
152NCT01484990
(ClinicalTrials.gov)
April 201028/7/2011A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's DiseaseA Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's DiseaseParkinson DiseaseDrug: Levodopa-CarbidopaAbbVieQuintiles, Inc.Completed30 Years99 YearsAll19Phase 1Germany;Sweden
153EUCTR2009-014688-37-PL
(EUCTR)
09/02/201020/01/2010A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/AA Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
154EUCTR2009-017416-33-DE
(EUCTR)
18/01/201021/12/2009Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. Male and female patients with Parkinson´s disease meeting UKPDS criteria
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
155EUCTR2008-001329-33-CZ
(EUCTR)
18/01/201003/12/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-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 IncNULLNot RecruitingFemale: yes
Male: yes
275Phase 3Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy
156EUCTR2009-014688-37-ES
(EUCTR)
30/12/200921/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Sinemet-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
157EUCTR2009-014688-37-DE
(EUCTR)
15/12/200907/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
158EUCTR2009-012897-12-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
159EUCTR2009-014688-37-FR
(EUCTR)
04/12/200909/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3France;Poland;Spain;Germany
160NCT01070628
(ClinicalTrials.gov)
December 200923/11/2009Levodopa Concentration Profile With Stalevo 75/125 mgLevodopa 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 GroupsParkinson's DiseaseDrug: Stalevo (levodopa/ carbidopa/ entacapone);Drug: Sinemet (levodopa/carbidopa)Orion Corporation, Orion PharmaNULLCompleted18 Years70 YearsBoth20Phase 1Finland
161NCT00660387
(ClinicalTrials.gov)
December 200915/4/2008Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll35Phase 3United States;New Zealand
162NCT00660673
(ClinicalTrials.gov)
November 13, 200915/4/2008Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PDOpen-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 StudiesAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pumpAbbVieIQVIA, formerly QuintilesCompleted30 Years99 YearsAll262Phase 3United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic
163EUCTR2008-001329-33-PT
(EUCTR)
02/10/200919/08/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
275Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand
164EUCTR2006-005186-18-NL
(EUCTR)
25/09/200929/05/2008Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
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
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
165NCT00918177
(ClinicalTrials.gov)
July 20091/6/2009An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's DiseaseDual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's PatientsParkinson's DiseaseDrug: AP09004;Drug: Carbidopa/Levodopa, immediate releaseIntec Pharma Ltd.NULLCompleted18 YearsN/ABoth72Phase 2Israel
166EUCTR2009-010193-38-LV
(EUCTR)
04/06/200924/08/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
167EUCTR2009-010193-38-LT
(EUCTR)
02/06/200926/03/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
168NCT00360568
(ClinicalTrials.gov)
June 20093/8/2006Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's SubjectsOpen-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsDyskinesias;Parkinson's Disease;Severe Motor FluctuationsDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll62Phase 3United States;Germany;New Zealand
169EUCTR2006-000578-53-DE
(EUCTR)
08/05/200930/10/2008Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsOpen-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 LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
70United States;Germany;New Zealand
170EUCTR2009-010193-38-EE
(EUCTR)
07/05/200915/04/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
171NCT00914602
(ClinicalTrials.gov)
May 20093/6/2009An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease SubjectsAn Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: Sinemet 25-100 Oral Tablet;Drug: XP21279;Drug: Carbidopa PillXenoPort, Inc.NULLCompleted30 Years75 YearsAll14Phase 1/Phase 2United States
172NCT00845000
(ClinicalTrials.gov)
April 21, 200913/2/2009Acute 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 PatientsParkinson DiseaseDrug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: CarbidopaMerck Sharp & Dohme Corp.Oregon Health and Science UniversityCompleted18 YearsN/AAll12Phase 1United States
173NCT01399905
(ClinicalTrials.gov)
March 200921/7/2011High and Low Dose Carbidopa Treatment of Parkinson's DiseaseA Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.Parkinson's DiseaseDrug: carbidopaOregon Health and Science UniversityNULLCompleted35 Years85 YearsAll14Phase 2United States
174EUCTR2006-005186-18-CZ
(EUCTR)
09/02/200921/11/2007Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” 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®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 Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand
175NCT00357994
(ClinicalTrials.gov)
January 200927/7/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll36Phase 3United States;Germany
176EUCTR2006-005186-18-GB
(EUCTR)
19/11/200827/06/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” 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®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 Healthcare Products B.V.NULLNot Recruiting Female: yes
Male: yes
320 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
177NCT00869791
(ClinicalTrials.gov)
November 200824/3/2009A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaA Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll27Phase 2United States
178EUCTR2008-003869-72-PT
(EUCTR)
03/10/200825/06/2008A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITORA DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Code: BIA 9-1067
Bial - Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
12Portugal
179EUCTR2006-005186-18-DE
(EUCTR)
30/09/200813/11/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” 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®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 Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
180EUCTR2004-005234-39-DE
(EUCTR)
11/08/200802/12/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden
181NCT00601978
(ClinicalTrials.gov)
August 200811/1/2008Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing OffA 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing OffParkinson's DiseaseDrug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/EntacaponeNovartis PharmaceuticalsNULLWithdrawn45 Years75 YearsBoth0Phase 4United States
182NCT00745277
(ClinicalTrials.gov)
August 20082/9/2008High and Low Dose Treatment of Carbidopa in Parkinson's DiseaseA Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.Parkinson's DiseaseDrug: Carbidopa-Levodopa;Drug: Carbidopa- LevodopaOregon Health and Science UniversityParkinson Disease Research, Education and Clinical Center at Portland VA Hospital;RJG Foundation;Oregon Clinical and Translational Research InstituteCompleted35 Years85 YearsBoth12Phase 2United States
183EUCTR2008-003581-26-SE
(EUCTR)
18/07/200830/05/2008Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMTPharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Duodopa
INN or Proposed INN: levodopa
INN or Proposed INN: carbidopa
Trade Name: Comtess
INN or Proposed INN: entacapone
Trade Name: Tasmar
INN or Proposed INN: tolcapone
Dept of Neuroscience, Uppsala UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
184EUCTR2007-003134-42-DE
(EUCTR)
19/06/200820/02/2008A 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 AGNULLNot RecruitingFemale: yes
Male: yes
20Germany
185EUCTR2007-005033-11-DE
(EUCTR)
27/03/200804/01/2008A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s DiseaseA Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease Patients with Parkinson's DiseaseProduct Name: Levodopa-Carbidopa Multilayer Extended Release Tablet
Product Code: Levodopa-Carbidopa XL tablet (M)
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet® CR
Product Name: Sinemet CR
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Germany
186EUCTR2006-005186-18-PT
(EUCTR)
07/03/200814/11/2007An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
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 Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
187NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffAn 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
188EUCTR2006-005186-18-IT
(EUCTR)
08/02/200814/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Duodopa gel intestinale
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals BV.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
189EUCTR2006-005186-18-ES
(EUCTR)
23/01/200829/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severasOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
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
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
190NCT00562198
(ClinicalTrials.gov)
January 200819/11/2007PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride BindingEffects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg 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 DiseaseDrug: entacapone and carbidopa;Drug: Sinemet 200mg/50mgOrion Corporation, Orion PharmaNULLTerminated45 Years80 YearsBoth16Phase 2Finland
191NCT00335153
(ClinicalTrials.gov)
January 20088/6/2006Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease MedicationsAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll354Phase 3United States;Australia;Canada;Czech Republic;Finland;Germany;Israel;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Spain;Thailand;United Kingdom;Greece
192EUCTR2004-000185-12-GB
(EUCTR)
13/12/200711/02/2005A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade 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
Trade Name: Sinemet
INN or Proposed INN: Levodopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot Recruiting Female: yes
Male: yes
740 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFinland;Austria;Italy;United Kingdom;Sweden
193EUCTR2007-004985-41-SE
(EUCTR)
29/11/200710/10/2007Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia studyDifferent dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study Parkinson's disease, G20.9. Different dyskinesias related to advanced Parkinson's disease will be investigated.Trade Name: Duodopa
INN or Proposed INN: levodopa
INN or Proposed INN: carbidopa
Department of Neuroscience, neurologyNULLNot RecruitingFemale: yes
Male: yes
Sweden
194EUCTR2006-005186-18-FI
(EUCTR)
16/11/200704/10/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
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
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
195EUCTR2007-002496-14-FI
(EUCTR)
05/11/200714/09/2007Effects 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
Finland
196NCT00558337
(ClinicalTrials.gov)
November 200712/11/2007Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's DiseaseAn Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease PatientsParkinson's DiseaseDrug: levodopa-carbidopaOsmotica Pharmaceutical Corp.NULLCompleted30 Years80 YearsBoth78Phase 2Argentina
197NCT00547911
(ClinicalTrials.gov)
October 200719/10/2007Augmenting Effects of L-DOPS With Carbidopa and EntacaponeL-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and EntacaponeParkinson Disease;Multiple System Atrophy;Autonomic Nervous System DiseasesDrug: Droxidopa;Drug: Carbidopa;Drug: EntacaponeNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 YearsN/AAll14Phase 1/Phase 2United States
198NCT00460954
(ClinicalTrials.gov)
June 200716/4/2007A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy SubjectsAn Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy SubjectsParkinson's DiseaseDrug: Sinemet® controlled release (Carbidopa/levodopa)Bristol-Myers SquibbNULLCompleted50 Years75 YearsBoth20N/ACanada
199NCT00505843
(ClinicalTrials.gov)
May 200724/7/2007A Study of MK0657 in Parkinson's Disease Patients (0657-006)A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopaMerck Sharp & Dohme Corp.NULLCompleted40 Years80 YearsBoth18Phase 1United States
200EUCTR2006-000577-29-DE
(EUCTR)
27/04/200712/10/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.0;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: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Trade Name: Sinemet®25-100
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)NULLNot RecruitingFemale: yes
Male: yes
31United States;Germany
201EUCTR2006-002408-32-ES
(EUCTR)
27/02/200707/02/2007Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa.Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson.
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo 150
Product Name: Levodopa-carbidopa-entacapone
Trade Name: Sinemet
Product Name: Levodopa/Carbidopa
Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain
202EUCTR2006-005714-12-IT
(EUCTR)
27/02/200703/08/2007A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations
MedDRA version: 6.1;Level: HLT;Classification code 10034005
Product Name: E2007
Product Code: E2007
INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS
Trade Name: SINEMET
INN or Proposed INN: levodopa-carbidopa
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
24Italy
203EUCTR2005-002654-21-NO
(EUCTR)
28/12/200606/11/2006A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinalgel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
75Norway;Sweden
204EUCTR2006-001755-36-GB
(EUCTR)
20/11/200629/09/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion PharmaNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGermany;United Kingdom;Sweden
205EUCTR2006-004112-51-IT
(EUCTR)
14/11/200604/12/2006A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - NDA randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND Parkinson s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: SIRIO*30CPR EFF 25MG+100MG
INN or Proposed INN: Melevodopa and decarboxylase inhibitor
Trade Name: SINEMET*50CPR 100MG+25MG
INN or Proposed INN: LEVODOPA DC.IT FU
INN or Proposed INN: CARBIDOPA FU
VERNALIS DEVELOPMENT LIMITEDNULLNot RecruitingFemale: yes
Male: yes
Italy
206NCT00590122
(ClinicalTrials.gov)
October 200628/12/2007Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison StudyCOMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIALParkinson's DiseaseDrug: Parcopa;Drug: carbidopa-levodopaBaylor College of MedicineUCB PharmaCompleted31 Years80 YearsBoth20Phase 4United States
207EUCTR2004-005234-39-LV
(EUCTR)
06/09/200629/09/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade 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
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
208EUCTR2006-001755-36-SE
(EUCTR)
09/08/200630/06/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion Pharma, FI-02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
209EUCTR2006-000680-28-ES
(EUCTR)
07/07/200622/05/2006Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBIEstudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI Enfermedad de Parkinson (Parkinson Disease)Trade Name: Stalevo 100
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
Trade Name: Sinemet plus
Product Name: Sinemet plus (levodopa/carbidopa)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Stalevo 150
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
NOVARTIS FARMACEUTICA, S.ANULLNot RecruitingFemale: yes
Male: yes
200Spain
210EUCTR2004-005234-39-LT
(EUCTR)
09/05/200624/03/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania
211EUCTR2005-001032-72-PT
(EUCTR)
23/03/200611/11/2005A 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 StepA 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 Parkinson diseaseTrade Name: Stalevo
Product Code: ELC200
INN or Proposed INN: levodopa/carbidopa/entacapone
Trade Name: SINEMET
Product Name: sinemet
INN or Proposed INN: levodopa/carbidopa
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
212NCT00141518
(ClinicalTrials.gov)
March 200630/8/2005Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic ImpactA Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/DyskinesiaAdvanced Idiopathic Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)AbbVie (prior sponsor, Abbott)NULLCompleted18 Years99 YearsAll77Phase 4Norway;Sweden
213EUCTR2005-001032-72-CZ
(EUCTR)
16/02/200612/01/2006A 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 StepA 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 AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
214NCT00279825
(ClinicalTrials.gov)
January 200618/1/2006Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's DiseaseA 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 DiseaseIdiopathic Parkinson's DiseaseDrug: 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 PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll16Phase 2United States
215EUCTR2005-001032-72-IT
(EUCTR)
25/11/200526/03/2007A 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 Parkinsons disease patients requiring levodopa.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 Parkinsons disease patients requiring levodopa. Parkinson s Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: ENTACAPONE INN
INN or Proposed INN: LEVODOPA INN
INN or Proposed INN: CARBIDOPA INN
Trade Name: Sinemet
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA ANIDRA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
216NCT00253084
(ClinicalTrials.gov)
November 200511/11/2005Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 2United States
217EUCTR2004-005234-39-IE
(EUCTR)
20/10/200516/08/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFinland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
218EUCTR2004-005234-39-FI
(EUCTR)
22/09/200503/06/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
219EUCTR2005-002654-21-SE
(EUCTR)
08/08/200514/06/2005A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinal gel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
Sweden
220EUCTR2004-005234-39-DK
(EUCTR)
04/08/200531/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
221NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 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 LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
222EUCTR2004-001485-41-GB
(EUCTR)
26/07/200521/06/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaser
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Spain
223NCT00143026
(ClinicalTrials.gov)
July 200531/8/2005Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United StatesStudy to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.Parkinson's DiseaseDrug: carbidopa, levodopa, entacaponeNovartisNULLCompleted30 YearsN/AAll184Phase 4Australia;Philippines;Taiwan;Thailand
224EUCTR2004-005234-39-SE
(EUCTR)
08/06/200502/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
225EUCTR2004-005234-39-GB
(EUCTR)
27/05/200522/03/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
Orion Corporation, ORION PHARMA, FinlandNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFinland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
226EUCTR2004-001485-41-ES
(EUCTR)
28/04/200530/01/2006A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s DiseaseA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: SINEMET
Product Name: carbodopa/levadopa
INN or Proposed INN: CARBODOPA LEVADOPA
Trade Name: SOLIGEN
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINA
Trade Name: DaTSCAN
INN or Proposed INN: Ioflupane [123I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United Kingdom;Spain
227EUCTR2004-001485-41-AT
(EUCTR)
20/04/200516/03/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaseril
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Spain;Austria;United Kingdom
228NCT00129181
(ClinicalTrials.gov)
January 20059/8/2005Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's DiseaseA Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's DiseaseParkinson Disease;Parkinsonian SyndromeDrug: cabergoline;Drug: carbidopa/levodopa;Procedure: DATscan and SPECT imagingInstitute for Neurodegenerative DisordersPfizer;GE HealthcareCompleted40 YearsN/ABoth30N/AAustria;Germany;Italy;Spain;United Kingdom
229NCT00219284
(ClinicalTrials.gov)
January 200530/6/2005Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's DiseaseA Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing OffParkinson's Disease With End of Dose Wearing OffDrug: Carbidopa/levodopa/entacaponeNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll359Phase 4United States;Puerto Rico
230EUCTR2004-000185-12-IT
(EUCTR)
02/12/200427/06/2005A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's diseaseA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
Product Name: NA
Product Code: NA
INN or Proposed INN: carbidopa
INN or Proposed INN: levodopa
INN or Proposed INN: entecapone
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
Trade Name: Stalevo
Product Name: NA
Product Code: NA
INN or Proposed INN: carbidopa
INN or Proposed INN: levodopa
INN or Proposed INN: entecapone
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
231EUCTR2004-000185-12-AT
(EUCTR)
25/11/200421/10/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name:
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;Austria;Italy;United Kingdom;Sweden
232EUCTR2004-000185-12-SE
(EUCTR)
11/11/200403/09/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name:
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
233EUCTR2004-000185-12-FI
(EUCTR)
21/09/200423/07/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade 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
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
234NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
235NCT00174239
(ClinicalTrials.gov)
July 20049/9/2005Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.Parkinson DiseaseDrug: cabergoline;Drug: controlled-release levodopa / carbidopaPfizerNULLTerminated18 Years80 YearsBoth220Phase 4Australia;Italy;Spain;United Kingdom
236NCT00200447
(ClinicalTrials.gov)
March 200412/9/2005An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)Parkinson's DiseaseDrug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imagingMolecular NeuroImagingNULLCompleted30 YearsN/ABoth3Phase 2NULL
237NCT00139867
(ClinicalTrials.gov)
January 200429/8/2005A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's DiseaseA Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's DiseaseParkinson's DiseaseDrug: PARCOPAUCB PharmaNULLCompleted18 YearsN/ABothPhase 3United States
238EUCTR2010-022200-46-DE
(EUCTR)
13/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.Efficacy and safety of ODM-101 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 motor fluctuations. - PARPOC Parkinson's disease
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: ODM-101
Product Code: 75
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
Product Name: ODM-101
Product Code: 100
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
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Latvia;Germany
239EUCTR2006-001755-36-DE
(EUCTR)
15/08/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden