Effect of Brivaracetam in Photosensitive Epileptic Subjects - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00401648

Purpose

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

Condition	Intervention	Phase
Epilepsy	Drug: Brivaracetam	Phase II

MedlinePlus related topics: Epilepsy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment
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.

Further study details as provided by UCB:

Primary Outcome Measures:

Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
post placebo during 24h and post brivaracetam for up to 72 h

Secondary Outcome Measures:

Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
Safety

Estimated Enrollment:	20
Study Start Date:	September 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401648

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

Philipp von Rosenstiel, MD.

UCB

More Information

Study ID Numbers:	N01069, Protocol Number RPCE02D2304
Study First Received:	November 17, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00401648
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

POC
photosensitive
epileptic

brivaracetam
PPR
AED

Study placed in the following topic categories:

Epilepsy
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009