Effect of Brivaracetam in Photosensitive Epileptic Subjects - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2006

Last Updated Date

March 7, 2008

Start Date ^†

September 2002

Current 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

Original 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 24 h and post brivaracetam for up to 72 hours

Change History

Complete list of historical versions of study NCT00401648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

Effect of Brivaracetam in Photosensitive Epileptic Subjects

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.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment

Condition ^†

Epilepsy

Intervention ^†

Drug: Brivaracetam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2003

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

epileptic subjects with generalized PPR

Exclusion Criteria:

more than 2 concomitant antiepileptic drugs

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France, Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00401648

Responsible Party

Secondary IDs ^††

Protocol Number RPCE02D2304

Study Sponsor ^†

UCB

Collaborators ^††

Investigators ^†

Study Director:

Philipp von Rosenstiel, MD.

UCB

Information Provided By

UCB

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.