6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-002754-24-DE (EUCTR) | 19/01/2022 | 14/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2020-002754-24-IT (EUCTR) | 09/09/2021 | 30/08/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg tablets Product Name: SINEMET 100 mg + 25 mg compresse Product Code: [023145028] INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: Carbidopa Trade Name: Madopar 125 mg T, tablets Product Name: Madopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride) Product Code: [6036937.00.01] INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: Levodopa Other descriptive name: Levodopa Trade Name: Ongentys 50 mg hard capsules Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone Other descriptive name: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2020-002754-24-ES (EUCTR) | 06/07/2021 | 09/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 4 | NCT04821687 (ClinicalTrials.gov) | June 17, 2021 | 25/3/2021 | A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD | A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease | Parkinson Disease | Drug: Ongentys 50mg;Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg | SK Chemicals Co., Ltd. | NULL | Recruiting | 30 Years | N/A | All | 200 | Phase 4 | Korea, Republic of |
| 5 | EUCTR2017-004006-18-NL (EUCTR) | 07/06/2018 | 15/11/2017 | The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease | Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease | Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: Madopar 125 mg, orodispersible tablet | Pharmaceutical Technology and Biopharmacy, University of Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 2 | Netherlands | ||
| 6 | NCT04968613 (ClinicalTrials.gov) | January 1, 2018 | 27/6/2021 | Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease | Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease | Parkinson Disease;Memory Impairment | Drug: Madopar monotherapy;Drug: senfrol monotherapy;Drug: placebo monotherapy | Peking University Third Hospital | Chinese Academy of Sciences | Recruiting | 50 Years | 80 Years | All | 150 | Phase 4 | China |
| 7 | NCT02741947 (ClinicalTrials.gov) | April 2014 | 31/3/2016 | Levodopa Benserazide Generic Formulation Versus the Originator | Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®) | Parkinson Disease | Drug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva Italia | IRCCS San Raffaele | Agenzia Italiana del Farmaco | Completed | 30 Years | 75 Years | Both | 44 | Phase 4 | Italy |
| 8 | EUCTR2012-001245-40-IT (EUCTR) | 05/06/2013 | 17/05/2013 | CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | PARKINSON'S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Madopar 200+50 mg Trade Name: LEVODOPA / BENSERAZIDE 200 + 50 MG | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 9 | EUCTR2010-022363-35-DE (EUCTR) | 18/02/2011 | 19/10/2010 | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar LT Product Name: Levodopa / Benserazid Product Code: LD / BE INN or Proposed INN: LEVODOPA Other descriptive name: - INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE Other descriptive name: - Trade Name: Neupro Product Name: Rotigotin Product Code: RO INN or Proposed INN: ROTIGOTINE Other descriptive name: - | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 10 | EUCTR2010-019354-40-AT (EUCTR) | 26/05/2010 | 26/04/2010 | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE | Universitätsklinik für Neurologie Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | 15 | Austria | |||
| 11 | NCT01568047 (ClinicalTrials.gov) | February 2010 | 29/3/2012 | Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients | Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon) | Parkinson's Disease | Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 40 | Phase 2 | Romania;Ukraine |
| 12 | ChiCTR-TRC-12002150 | 2009-09-29 | 2012-05-06 | Study on Optimization of The Comprehensive Therapeutic Plan for Parkinson's Disease in Different Stages | Study on Optimization of The Comprehensive Therapeutic Plan by Stages for Parkinson's Disease | Parkinson's Disease | The early treatment group:Xifeng Dingchan Pill;The early control group:Madopar tablets;Interim treatment group:Xifeng Dingchan Pill, Madopar tablets and Piribedil tablets; | Henan University of Traditional Chinese Medicine | NULL | Recruiting | 50 | 75 | Both | The early treatment group:80;The early control group:80;Interim treatment group:160; | China | |
| 13 | NCT02169466 (ClinicalTrials.gov) | January 2009 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Portugal |
| 14 | ChiCTR-TRC-07000027 | 2007-11-01 | 2007-11-09 | A randomized controlled clinical study of Pramipexole for Parkinson's disease | A randomized controlled clinical study of Pramipexole for Parkinson's disease | Primary Parkinson's disease | Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease; | First Affiliated Hospital of Xinjiang Medical University | NULL | Completed | 30 | 80 | Both | Group 1:45;Group 3:45;Group 2:45; | China | |
| 15 | NCT03097211 (ClinicalTrials.gov) | July 17, 2006 | 27/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Nebicapone | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 38 | Phase 1 | Portugal |
| 16 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 17 | NCT02778594 (ClinicalTrials.gov) | September 2005 | 18/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide (Madopar® HBS 125): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy Volunteers | Parkinson's Disease (PD) | Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 17 | Phase 1 | Portugal |
| 18 | NCT03091543 (ClinicalTrials.gov) | May 4, 2004 | 21/3/2017 | Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg | Parkinson Disease | Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Portugal |
| 19 | NCT02763852 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 18 | Phase 1 | Portugal |