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

April 23, 2008 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Den Haag, Netherlands, 2501 CK
        • Pfizer Investigational Site
      • Heeze, Netherlands, 5591 VE
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
Time Frame: Endpoint
Endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total sleep time
Time Frame: Endpoint
Endpoint
Change from baseline in sleep onset latency
Time Frame: Endpoint
Endpoint
Change from baseline in wake after sleep onset
Time Frame: Endpoint
Endpoint
Change from baseline in percent sleep spent in stages 3 and 4
Time Frame: Endpoint
Endpoint
Change from baseline in percent sleep spent in REM stage
Time Frame: Endpoint
Endpoint
Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)
Time Frame: Endpoint
Endpoint
Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)
Time Frame: Endpoint
Endpoint
Adverse events and laboratory value changes
Time Frame: Endpoint
Endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008-000-167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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