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A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

Last updated on March 14, 2019

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Study Location
Pediatric Epilepsy Center of Central Florida
Orlando, Florida, 32819 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Onset Seizures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-3 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT02072824
Pfizer
Completed
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

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