BRIVARACETAM ( DrugBank: Brivaracetam )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 149 | 片側痙攣・片麻痺・てんかん症候群 | 3 |
| 309 | 進行性ミオクローヌスてんかん | 9 |
149. 片側痙攣・片麻痺・てんかん症候群
臨床試験数 : 25 / 薬物数 : 40 - (DrugBank : 14) / 標的遺伝子数 : 17 - 標的パスウェイ数 : 20
| 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 | JPRN-JapicCTI-184137 | 04/1/2019 | 03/10/2018 | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replaement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age with Partial Seizures With or Without Secondary Generalization | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replaement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age with Partial Seizures With or Without Secondary Generalization | Epilepsy and epilepsy syndrome | Intervention name : brivaracetam INN of the intervention : brivaracetam Dosage And administration of the intervention : Intravenous (iv) injection Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | complete | 16 | BOTH | 10 | Phase 3 | Japan | |
| 2 | JPRN-JapicCTI-173615 | 22/8/2017 | 15/06/2017 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization | Epilepsy and epilepsy syndrome | Intervention name : ucb 34714 INN of the intervention : Brivaracetam Dosage And administration of the intervention : Oral administration Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | recruiting | 16 | 80 | BOTH | 444 | Phase 3 | Japan, Asia except Japan |
| 3 | JPRN-JapicCTI-173687 | 05/8/2017 | 21/08/2017 | An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization | An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization | Epilepsy and epilepsy syndrome | Intervention name : brivaracetam INN of the intervention : brivaracetam Dosage And administration of the intervention : Oral administration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | recruiting | 16 | BOTH | 214 | Phase 3 | Japan, Asia except Japan |
309. 進行性ミオクローヌスてんかん
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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Finland;France | |||
| 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Finland;France | |||
| 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 |