Effect of Brivaracetam in Photosensitive Epileptic Subjects

Epilepsy Clinical Trial

Official title:

A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401648
• Other study ID #: N01069
• Secondary ID: Protocol Number
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2006
• Last updated: November 30, 2009
• Start date: September 2002
• Est. completion date: June 2003

Study information

• Verified date: November 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• epileptic subjects with generalized PPR

Exclusion Criteria:

• more than 2 concomitant antiepileptic drugs

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
Primary	post placebo during 24h and post brivaracetam for up to 72 h
Secondary	Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Secondary	Safety