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Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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Viatris

Status and phase

Terminated
Phase 3

Conditions

Epilepsies, Partial

Treatments

Drug: pregabalin 150 mg/day
Drug: pregabalin 600 mg/day

Study type

Interventional

Funder types

Industry

Identifiers

NCT00524030
A0081047

Details and patient eligibility

About

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Full description

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Enrollment

161 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of epilepsy with partial seizures.
  • Males or females, age 18 years or older.
  • Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
  • Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion criteria

  • Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
  • Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
  • Primary generalized epilepsy or status epilepticus within the previous year.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

161 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: pregabalin 600 mg/day
2
Experimental group
Treatment:
Drug: pregabalin 150 mg/day

Trial contacts and locations

73

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Data sourced from clinicaltrials.gov

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