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- Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
- Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs
- Primary generalized seizures (for example, absence, myoclonic seizures or
Lennox-Gastaut Syndrome)
- Status epilepticus within one year prior to screening
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Descriptive Information | ||||
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Brief Title ICMJE | Once-A-Day Pregabalin For Partial Seizures | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures | |||
Brief Summary | Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 325 | |||
Original Estimated Enrollment ICMJE | 333 | |||
Actual Study Completion Date ICMJE | August 1, 2012 | |||
Actual Primary Completion Date | July 31, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hong Kong, Hungary, India, Malaysia, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Thailand, United States | |||
Removed Location Countries | Croatia, Czech Republic, South Africa | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01262677 | |||
Other Study ID Numbers ICMJE | A0081194 2010-019035-35 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |