Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

Viatris

Status and phase: Completed; Phase 3

Conditions: Epilepsies, Partial

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448916

A0081075

2010-020731-39 (EudraCT Number)

Details and patient eligibility

About

The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.

Enrollment: 54 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
• Completion of study A0081074

Exclusion criteria

• Primary generalized seizures
• Progressive CNS pathology
• Failure to tolerate pregabalin in study A0081074

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Pregabalin

Experimental group

Description:

Orally-administered pregabalin

Treatment:

Drug: Pregabalin