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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00643136
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 24, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Sleep Deprivation Epilepsies, Partial Drug: Pregabalin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2002
Actual Study Completion Date : June 2004

Arm Intervention/treatment
Experimental: Pregabalin Drug: Pregabalin
Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
Placebo Comparator: Placebo Drug: Placebo
Matching placebo capsules twice daily for 28 days

Primary Outcome Measures :
  1. Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population [ Time Frame: Endpoint ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00643136

Pfizer Investigational Site
Den Haag, Netherlands, 2501 CK
Pfizer Investigational Site
Heeze, Netherlands, 5591 VE
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00643136     History of Changes
Other Study ID Numbers: 1008-000-167
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Sleep Deprivation
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Wake Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs