A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any - 3 |
| Updated: | 10/11/2018 |
| Start Date: | September 16, 2014 |
| End Date: | March 13, 2018 |
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
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce
seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with
refractory partial onset seizures. It is hypothesized that both doses of pregabalin will
demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure
frequency and that pregabalin will be safe and well tolerated.
seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with
refractory partial onset seizures. It is hypothesized that both doses of pregabalin will
demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure
frequency and that pregabalin will be safe and well tolerated.
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-epileptic drugs at screening.
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
encephalopathy.
- Progressive errors of metabolism.
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sites
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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