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Trial record 1 of 1 for:    NCT00643136
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A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures

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ClinicalTrials.gov Identifier: NCT00643136
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 26, 2008
Last Update Posted Date April 24, 2008
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population [ Time Frame: Endpoint ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00643136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Deprivation
  • Epilepsies, Partial
Intervention  ICMJE
  • Drug: Pregabalin
    Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
  • Drug: Placebo
    Matching placebo capsules twice daily for 28 days
Study Arms  ICMJE
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643136
Other Study ID Numbers  ICMJE 1008-000-167
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP