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Effect of Brivaracetam in Photosensitive Epileptic Subjects

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00401648
First received: November 17, 2006
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Epilepsy
 Drug: Brivaracetam
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epileptic subjects with generalized PPR

Exclusion Criteria:

  • more than 2 concomitant antiepileptic drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401648

Locations
France
Marseille, France
Paris, France
Rouen, France
Strasbourg, France
Germany
Kork, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Philipp von Rosenstiel, MD. UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00401648     History of Changes
Other Study ID Numbers: N01069, Protocol Number RPCE02D2304
Study First Received: November 17, 2006
Last Updated: November 30, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
POC
photosensitive
epileptic
 brivaracetam
PPR
AED

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013