A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 1 MONTH THROUGH <4 YEARS OF AGE WITH PARTIAL ONSET SEIZURES - Pregabalin, Phase 3 Study in children < 4 years of age with partial onset seizures
- Conditions
- Partial onset seizuresMedDRA version: 18.0Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-003420-37-PT
- Lead Sponsor
- Pfizer Inc. 235 East 42nd Street, New York, NY 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
- Subject must have 3 partial onset seizures in the month prior to screening.
- Subject must have 2 partial onset seizures during the 48 hour baseline phase.
- Signed Informed Consent
- On 1-3 stable anti-eplieptic drugs at screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 123
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms
- Lennox-Gasteau, BECTS, and Dravet's syndrome
- Status epliepticus within 1 year of screening
- Any change in AED regimen with 7 days of screening
- Progressive structural central nervous system (CNS) lesion or a progressive encepholopathy
- Progressive errors of metabolism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method