Once-A-Day Pregabalin For Partial Seizures

Viatris

Status and phase: Completed; Phase 3

Conditions: Epilepsies, Partial; Partial Seizures

Treatments: Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262677

A0081194

2010-019035-35 (EudraCT Number)

Details and patient eligibility

About

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
• Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion criteria

• Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
• Status epilepticus within one year prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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325 participants in 3 patient groups, including a placebo group

pregabalin CR 330 mg

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

pregabalin CR 165 mg

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Drug: pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo