A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 years of age with Partial Onset seizures.

Phase 1

• Conditions: Partial onset seizures; MedDRA version: 17.0Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-003420-37-GR
• Lead Sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-17
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

- 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

Exclusion Criteria

- 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