CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 853 enrolled
Drug / intervention
Brivaracetam (ucb 34714)drug
Likely dose
Brivaracetam 10–25 mg tablets, flexible dosing up to 200 mg/day, twice dailyAI-extracted
Key inclusion· 3
  • ✓Age ≥16 years (or ≥18 where legally required) with epilepsy
  • ✓Completed a previous brivaracetam study that allows access to this follow-up trial
  • ✓Investigator believes reasonable benefit from long-term brivaracetam administration may be expected
Key exclusion· 5
  • ✕Severe medical, neurological, or psychiatric disorders
  • ✕Laboratory values that may impact subject safety
  • ✕Poor compliance with visit schedule or medication in previous brivaracetam study
  • ✕Concurrent participation in another clinical study of investigational drug or device

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00175916
NCT00175916Phase 3Completed
CompareCT.gov

An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

UCB Pharma·interventional·Posted Sep 15, 2005·Updated Aug 17, 2021

In Brief

A Phase 3 clinical trial evaluating Brivaracetam (ucb 34714) for Epilepsy. Completed, enrolled 853 participants across 153 sites in 26 countries.

Detailed Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustria, Belgium, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Norway, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 13.7 yearsPosted 20.8 years ago

Interventions

Brivaracetam (ucb 34714)drug

10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.