Pregabalin Epilepsy Add-On Trial

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs

• Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion Criteria:

• Have a treatable cause of seizures

• Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)