Carbidopa-levodopa ( DrugBank: Carbidopa, Levodopa )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
4原発性側索硬化症1
6パーキンソン病29

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 623 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03929068
(ClinicalTrials.gov)
May 13, 201910/4/2019Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral SclerosisSinemet in ALS and PLSAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: carbidopa-levodopa;Drug: Placebo Oral TabletWashington University School of MedicineNULLEnrolling by invitation18 YearsN/AAll15Phase 1United States

4. 原発性側索硬化症


臨床試験数 : 7 薬物数 : 17 - (DrugBank : 9) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 32
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03929068
(ClinicalTrials.gov)
May 13, 201910/4/2019Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral SclerosisSinemet in ALS and PLSAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: carbidopa-levodopa;Drug: Placebo Oral TabletWashington University School of MedicineNULLEnrolling by invitation18 YearsN/AAll15Phase 1United States

6. パーキンソン病


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05128175
(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
2NCT05036473
(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
3NCT04590612
(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
4EUCTR2018-002233-37-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
5EUCTR2018-002233-37-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
6EUCTR2018-002233-37-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
7EUCTR2018-002233-37-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
8EUCTR2018-002233-37-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
9NCT03670953
(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
10EUCTR2018-001209-95-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
11NCT03576638
(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
12EUCTR2017-002780-17-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
13EUCTR2017-002780-17-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
14EUCTR2017-002780-17-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
15EUCTR2016-001403-23-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
16EUCTR2016-001403-23-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
17EUCTR2016-001403-23-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
18NCT02799381
(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
19EUCTR2016-001403-23-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
20EUCTR2016-001403-23-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
21EUCTR2016-001403-23-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
22NCT02812394
(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
23NCT01411137
(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
24NCT01528592
(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
25NCT00869791
(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
26NCT00745277
(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
27NCT00590122
(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
28NCT00279825
(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
29NCT00253084
(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