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

NCT ID: NCT00643136

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-06-30

Brief Summary

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

Detailed Description

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Conditions

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Sleep Deprivation Epilepsies, Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pregabalin

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules twice daily for 28 days

Interventions

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Pregabalin

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

Intervention Type DRUG

Placebo

Matching placebo capsules twice daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Heeze, , Netherlands

Site Status

Pfizer Investigational Site

The Hague, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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1008-000-167

Identifier Type: -

Identifier Source: org_study_id