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A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

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UCB

Status and phase

Completed
Phase 2

Conditions

Epilepsy

Treatments

Other: Placebo
Drug: Brivaracetam

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Enrollment

210 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male/female from 16 to 65 years
  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • History of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
  • Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion criteria

  • Seizure type IA non-motor as only seizure type
  • Seizures occurring only in clusters
  • Status epilepticus during the last 2 years before Visit 1
  • 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

210 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Matching Placebo tablets administered twice a day
Treatment:
Other: Placebo
Brivaracetam 5 mg/day
Experimental group
Description:
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Treatment:
Drug: Brivaracetam
Brivaracetam 20 mg/day
Experimental group
Description:
Brivaracetam 20 mg/day, 10 mg administered twice a day
Treatment:
Drug: Brivaracetam
Brivaracetam 50 mg/day
Experimental group
Description:
Brivaracetam 50 mg/day, 25 mg administered twice a day
Treatment:
Drug: Brivaracetam

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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