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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00401648 |
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Date of registration:
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17/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Brivaracetam in Photosensitive Epileptic Subjects
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Scientific title:
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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. |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00401648 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Germany
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Contacts
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Name:
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Philipp von Rosenstiel, MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCB Pharma |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- epileptic subjects with generalized PPR
Exclusion Criteria:
- more than 2 concomitant antiepileptic drugs
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: Brivaracetam
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Primary Outcome(s)
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post placebo during 24h and post brivaracetam for up to 72 h
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Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
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Secondary Outcome(s)
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Safety
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Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
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Secondary ID(s)
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Protocol Number RPCE02D2304
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N01069
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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