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

Phase 3CompletedNCT00643136

Pfizer17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Deprivation Epilepsies, Partial

Interventions

PregabalinDRUG

Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28

PlaceboDRUG

Matching placebo capsules twice daily for 28 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

Heeze, Netherlands

Pfizer Investigational Site

The Hague, Netherlands

Outcomes

Primary Outcomes

Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population

Time frame: Endpoint

Secondary Outcomes

Change from baseline in total sleep time

Time frame: Endpoint

Change from baseline in sleep onset latency

Time frame: Endpoint

Change from baseline in wake after sleep onset

Time frame: Endpoint

Change from baseline in percent sleep spent in stages 3 and 4

Time frame: Endpoint

Change from baseline in percent sleep spent in REM stage

Time frame: Endpoint

Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)

Time frame: Endpoint

Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)

Time frame: Endpoint

Adverse events and laboratory value changes

Time frame: Endpoint

Data from ClinicalTrials.gov

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