ClinicalTrials.Veeva

Menu

A Study of Brivaracetam in Subjects With Partial Onset Seizures

UCB logo

UCB

Status and phase

Completed
Phase 2

Conditions

Epilepsy, Focal

Treatments

Other: Placebo
Drug: Brivaracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00175929
N01114
2004-001856-35 (EudraCT Number)

Details and patient eligibility

About

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

Enrollment

157 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • Subjects with a history of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
  • Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
  • Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion criteria

  • Seizure type IA non-motor as only seizure type
  • History or presence of seizures occurring only in clustered patterns
  • History of cerebrovascular accident (CVA)
  • Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

157 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Matching placebo tablets administered twice a day
Treatment:
Other: Placebo
Brivaracetam 50 mg/day
Experimental group
Description:
Brivaracetam 50 mg/day, 25 mg administered twice a day
Treatment:
Drug: Brivaracetam
Drug: Brivaracetam
Brivaracetam 150 mg/day
Experimental group
Description:
Brivaracetam 150 mg/day, 75 mg administered twice a day
Treatment:
Drug: Brivaracetam
Drug: Brivaracetam

Trial contacts and locations

57

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems