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-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 | ||
| 2 | EUCTR2014-002295-87-IT (EUCTR) | 13/10/2014 | 29/09/2014 | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | Parkinson's disease patients who suffer motor fluctuations willparticipate in the study MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg compresse Product Name: SINEMET 100 mg + 25 mg compresse Product Code: NA | SynAgile Corporation | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy |