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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 19, 2008
Last updated: April 23, 2008
Last verified: April 2008
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.

Condition Intervention Phase
Sleep Deprivation Epilepsies, Partial Drug: Pregabalin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: November 2002
Study Completion Date: June 2004
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00643136     History of Changes
Other Study ID Numbers: 1008-000-167
Study First Received: March 19, 2008
Last Updated: April 23, 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 processed this record on August 18, 2017