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

Primary Purpose

Sleep Deprivation, Epilepsies, Partial

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

Pregabalin

Placebo

About this trial

This is an interventional treatment trial for Sleep Deprivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population

Secondary Outcome Measures

Change from baseline in total sleep time

Change from baseline in sleep onset latency

Change from baseline in wake after sleep onset

Change from baseline in percent sleep spent in stages 3 and 4

Change from baseline in percent sleep spent in REM stage

Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)

Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)

Adverse events and laboratory value changes

Full Information

NCT ID

NCT00643136

First Posted

March 19, 2008

Last Updated

April 23, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00643136

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Epilepsies, Partial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Intervention Description

Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo capsules twice daily for 28 days

Primary Outcome Measure Information:

Title

Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population

Time Frame

Endpoint

Secondary Outcome Measure Information:

Title

Change from baseline in total sleep time

Time Frame

Endpoint

Title

Change from baseline in sleep onset latency

Time Frame

Endpoint

Title

Change from baseline in wake after sleep onset

Time Frame

Endpoint

Title

Change from baseline in percent sleep spent in stages 3 and 4

Time Frame

Endpoint

Title

Change from baseline in percent sleep spent in REM stage

Time Frame

Endpoint

Title

Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)

Time Frame

Endpoint

Title

Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)

Time Frame

Endpoint

Title

Adverse events and laboratory value changes

Time Frame

Endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Den Haag

ZIP/Postal Code

2501 CK

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Heeze

ZIP/Postal Code

5591 VE

Country

Netherlands

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=1008-000-167&StudyName=A%20study%20of%20Lyrica%20as%20treatment%20for%20sleep%20problems%20in%20patients%20with%20sleep%20problems%20and%20seizures

Description

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Learn more about this trial

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

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