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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: |
NCT00143143 |
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Date of registration:
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30/08/2005 |
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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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Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
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Scientific title:
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Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures |
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Date of first enrolment:
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September 2001 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00143143 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Canada
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France
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Germany
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Italy
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Lithuania
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Spain
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United Kingdom
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have met the inclusion criteria for Study 1008-157, have received
double-blind study medication, and wish to receive open-label pregabalin
- Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial
seizures during the 6 weeks prior to screening
- Be currently taking 1 to 3 AEDs.
Exclusion Criteria:
- Have a treatable cause of seizures
- Experienced a serious adverse event during Study 1008-157 which was determined to be
possibly related to study medication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsies, Partial
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Epilepsy, Complex Partial
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Intervention(s)
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Drug: Pregabalin
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Primary Outcome(s)
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Safety assessments are performed at quarterly visits up until the study is closed.
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Secondary Outcome(s)
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Seizure frequency is assessed throughout the study until the study is closed.
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Secondary ID(s)
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1008-000-164
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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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