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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-184137
04/1/201903/10/2018A 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 GeneralizationA 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 syndromeIntervention 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.NULLcomplete16BOTH10Phase 3Japan
2JPRN-JapicCTI-173615
22/8/201715/06/2017A 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 GeneralizationA 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 syndromeIntervention 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.NULLrecruiting1680BOTH444Phase 3Japan, Asia except Japan
3JPRN-JapicCTI-173687
05/8/201721/08/2017An 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 GeneralizationAn 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 syndromeIntervention 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.NULLrecruiting16BOTH214Phase 3Japan, 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-000169-12-IT
(EUCTR)
26/01/200710/01/2007A 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. - NDA 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 MadreNULLNot RecruitingFemale: yes
Male: yes
42Finland;Netherlands;France;Italy;Sweden
2EUCTR2006-000169-12-NL
(EUCTR)
27/12/200628/09/2006A 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.NULLNot RecruitingFemale: yes
Male: yes
42Finland;Netherlands;France;Italy;Sweden
3EUCTR2006-001536-46-FI
(EUCTR)
21/11/200610/10/2006A 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 trialA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Finland;France
4EUCTR2006-001536-46-FR
(EUCTR)
14/11/200625/08/2006A 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 trialA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Finland;France
5EUCTR2006-000169-12-FR
(EUCTR)
03/11/200625/08/2006A 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.NULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Finland;Netherlands;Italy;Sweden
6NCT00357669
(ClinicalTrials.gov)
November 200625/7/2006Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and AdultsA 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 DiseaseUnverricht-Lundborg DiseaseDrug: Brivaracetam 25 mg;Drug: Brivaracetam 50 mg;Other: PlaceboUCB Pharma SANULLCompleted16 YearsN/ABoth50Phase 3Finland;France;Italy;Netherlands;Réunion;Sweden;Tunisia
7NCT00368251
(ClinicalTrials.gov)
November 200623/8/2006Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and AdultsA 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 DiseaseUnverricht-Lundborg DiseaseOther: Placebo;Drug: BRV 2.5 mg;Drug: BRV 25 mg;Drug: BRV 50 mgUCB PharmaNULLCompleted16 YearsN/AAll56Phase 3United States;Canada;Finland;France;Israel;Russian Federation;Serbia;Tunisia;Former Serbia and Montenegro
8EUCTR2006-000169-12-SE
(EUCTR)
06/10/200607/08/2006A 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.NULLNot RecruitingFemale: yes
Male: yes
45Finland;Netherlands;France;Italy;Sweden
9EUCTR2006-000169-12-FI
(EUCTR)
28/09/200631/07/2006A 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.NULLNot RecruitingFemale: yes
Male: yes
42Finland;Netherlands;France;Italy;Sweden