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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643136
First received: March 19, 2008
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total sleep time [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in sleep onset latency [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in wake after sleep onset [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in percent sleep spent in stages 3 and 4 [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in percent sleep spent in REM stage [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ) [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale) [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Adverse events and laboratory value changes [ Time Frame: Endpoint ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00643136

Locations
Netherlands
Pfizer Investigational Site
Den Haag, Netherlands, 2501 CK
Pfizer Investigational Site
Heeze, Netherlands, 5591 VE
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643136     History of Changes
Other Study ID Numbers: 1008-000-167
Study First Received: March 19, 2008
Last Updated: April 23, 2008
Health Authority: Netherlands: The Dutch Health Inspectorate

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Sleep Deprivation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyssomnias
Sleep Disorders
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 28, 2014