Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.

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Detailed Description

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Conditions

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Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GSK189254

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Narcolepsy patients
* Body mass index between 18 - 32 kg/m2
* Females may be of child bearing or non-child bearing potential.
* Agreement to refrain from driving or operating heavy machinery for the duration of the study.
* Must be able to withdraw from medication for the treatment of daytime sleepiness and must not be living on their own.

Exclusion Criteria

* History or presence of major psychiatric disorder or depression.
* History of significant head trauma in the previous 12 months.
* Participation in a clinical trial in the previous 3 months.
* Patient has significant and recent (within 1 year) history of drug or alcohol abuse.
* Patient is pregnant or breast-feeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No