A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures

Pfizer

Status and phase: Completed; Phase 3

Conditions: Sleep Deprivation; Epilepsies, Partial

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643136

1008-000-167

Details and patient eligibility

About

The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partial epileptic seizures
• Not taking more than 1 background antiepileptic drug at study entry
• Disturbed sleep

Exclusion criteria

• More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
• Medical, psychological, or social conditions that could interfere with normal sleep

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo