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Trial record 1 of 1 for:    NCT00401648
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Effect of Brivaracetam in Photosensitive Epileptic Subjects

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ClinicalTrials.gov Identifier: NCT00401648
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
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.
Study Start Date : September 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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

Secondary Outcome Measures :
  1. Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
  2. Safety

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epileptic subjects with generalized PPR

Exclusion Criteria:

  • more than 2 concomitant antiepileptic drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401648


Locations
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France
Marseille, France
Paris, France
Rouen, France
Strasbourg, France
Germany
Kork, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: Philipp von Rosenstiel, MD. UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00401648    
Other Study ID Numbers: N01069
Protocol Number RPCE02D2304
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009
Keywords provided by UCB Pharma:
POC
photosensitive
epileptic
 brivaracetam
PPR
AED
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Brivaracetam
Anticonvulsants