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Pregabalin Epilepsy Add-On Trial

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Viatris

Status and phase

Completed
Phase 3

Conditions

Partial Seizures

Treatments

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141258
A0081079

Details and patient eligibility

About

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

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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