Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

Viatris

Status and phase: Completed; Phase 2; Phase 1

Conditions: Epilepsies, Partial

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437281

A0081074

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Enrollment: 65 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partial onset seizures, incompletely controlled on 1-3 medications
• At least 1 seizure per 28 days, on average

Exclusion criteria

• Primary generalized seizures
• Progressive CNS pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Pregabalin

Experimental group

Treatment:

Drug: Pregabalin