309. 進行性ミオクローヌスてんかん Progressive myoclonus epilepsy Clinical trials / Disease details
臨床試験数 : 11 / 薬物数 : 15 - (DrugBank : 2) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 9
| 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 | EUCTR2006-000169-12-IT (EUCTR) | 26/01/2007 | 10/01/2007 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients above or equal to 16 years with genetically ascertained Unverricht-Lundborg disease. - ND | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients above or equal to 16 years with genetically ascertained Unverricht-Lundborg disease. - ND | Unverricht-Lundborg Disease MedDRA version: 6.1;Level: PT;Classification code 10054895 | Product Name: BRIVARACETAM Product Name: BRIVARACETAM | UCB S.A. Casa Madre | NULL | Not Recruiting | Female: yes Male: yes | 42 | Finland;Netherlands;France;Italy;Sweden | |||
| 2 | EUCTR2006-000169-12-NL (EUCTR) | 27/12/2006 | 28/09/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 42 | Finland;Netherlands;France;Italy;Sweden | |||
| 3 | EUCTR2006-001536-46-FI (EUCTR) | 21/11/2006 | 10/10/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. - ULD trial | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. - ULD trial | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Finland | ||
| 4 | EUCTR2006-001536-46-FR (EUCTR) | 14/11/2006 | 25/08/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. - ULD trial | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. - ULD trial | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide Product Name: Brivaracetam Product Code: ucb 34714 Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-y1] butanamide | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Finland | ||
| 5 | EUCTR2006-000169-12-FR (EUCTR) | 03/11/2006 | 25/08/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Finland;Netherlands;Italy;Sweden | ||
| 6 | NCT00368251 (ClinicalTrials.gov) | November 2006 | 23/8/2006 | Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (= 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease | Unverricht-Lundborg Disease | Other: Placebo;Drug: BRV 2.5 mg;Drug: BRV 25 mg;Drug: BRV 50 mg | UCB Pharma | NULL | Completed | 16 Years | N/A | All | 56 | Phase 3 | United States;Canada;Finland;France;Israel;Russian Federation;Serbia;Tunisia;Former Serbia and Montenegro |
| 7 | NCT00357669 (ClinicalTrials.gov) | November 2006 | 25/7/2006 | Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (=16 Years) With Genetically Ascertained Unverricht-Lundborg Disease | Unverricht-Lundborg Disease | Drug: Brivaracetam 25 mg;Drug: Brivaracetam 50 mg;Other: Placebo | UCB Pharma SA | NULL | Completed | 16 Years | N/A | Both | 50 | Phase 3 | Finland;France;Italy;Netherlands;Réunion;Sweden;Tunisia |
| 8 | EUCTR2006-000169-12-SE (EUCTR) | 06/10/2006 | 07/08/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 45 | Finland;Netherlands;France;Italy;Sweden | |||
| 9 | EUCTR2006-000169-12-FI (EUCTR) | 28/09/2006 | 31/07/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | A multicenter, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of brivaracetam used as adjunctive treatment for 12 weeks in adolescent and adult patients (=16 years) with genetically ascertained Unverricht-Lundborg disease. | Patients with genetically ascertained Unverricht-Lundborg disease (ULD). MedDRA version: 8.1;Level: LLT;Classification code 10054894;Term: Unverricht-Lundborg disease | Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide Product Name: Brivaracetam Product Code: ucb 34714 INN or Proposed INN: brivaracetam Other descriptive name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 42 | Finland;Netherlands;France;Italy;Sweden |