CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 668 enrolled
Drug / intervention
Brivaracetamdrug
Likely dose
Brivaracetam 10 mg or 25 mg tablets orally, flexible dose up to maximum 200 mg/dayAI-extracted
Key inclusion· 5
  • ✓Age 16 years or older (subjects under 18 only where legally permitted and ethically accepted)
  • ✓Epilepsy diagnosis with prior participation in previous brivaracetam trials that allow access to this study
  • ✓Investigator believes reasonable benefit from long-term brivaracetam administration may be expected
  • ✓Female subjects of childbearing potential must use medically accepted contraceptive method for study duration
Key exclusion· 4
  • ✕Severe medical, neurological, or psychiatric disorders or laboratory abnormalities that may impact subject safety
  • ✕Poor compliance with visit schedule or medication intake in previous brivaracetam study
  • ✕Pregnancy or lactation
  • ✕Concurrent participation in any other clinical trial of investigational drug or device

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

Search/NCT00150800
NCT00150800Phase 3Completed
CompareCT.gov

An Open-label, Multi-center, 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 Inc. (US)·interventional·Posted Sep 8, 2005·Updated Aug 17, 2021

In Brief

A Phase 3 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 668 participants across 100 sites in 6 countries.

Detailed Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Brazil, Canada, India, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 20.8 years ago

Interventions

Brivaracetamdrug

* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 10 mg and 25 mg * Route of Administration: Oral