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Completed

NCT Number: NCT00643136

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

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

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Key information

Conditions

Sleep Deprivation Brain Diseases Central Nervous System Diseases Dyssomnias Epilepsies, Partial Epilepsy Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Heeze, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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

Placebo

Drug

Matching placebo capsules twice daily for 28 days

Primary outcomes

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

    Time frame: Endpoint

Secondary outcomes

  1. Change from baseline in total sleep time

    Time frame: Endpoint

  2. Change from baseline in sleep onset latency

    Time frame: Endpoint

  3. Change from baseline in wake after sleep onset

    Time frame: Endpoint

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

    Time frame: Endpoint

  5. Change from baseline in percent sleep spent in REM stage

    Time frame: Endpoint

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

    Time frame: Endpoint

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

    Time frame: Endpoint

  8. Adverse events and laboratory value changes

    Time frame: Endpoint

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment

Important dates

Study start
2002
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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