A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
Phase 3
Completed
- Conditions
- Sleep DeprivationEpilepsies, Partial
- Interventions
- Drug: Placebo
- Registration Number
- NCT00643136
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Pregabalin Pregabalin -
- Primary Outcome Measures
Name Time Method Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population Endpoint
- Secondary Outcome Measures
Name Time Method Change from baseline in total sleep time Endpoint Change from baseline in sleep onset latency Endpoint Change from baseline in wake after sleep onset Endpoint Change from baseline in percent sleep spent in stages 3 and 4 Endpoint Change from baseline in percent sleep spent in REM stage Endpoint Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ) Endpoint Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale) Endpoint Adverse events and laboratory value changes Endpoint
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇳🇱Heeze, Netherlands