Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

This study has been terminated.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00366080

First received: August 17, 2006

Last updated: March 10, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2006

Last Updated Date

March 10, 2011

Start Date ^ICMJE

November 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Sleep Latency as measured by the Maintenance of Wakefulness test (this test evaluates alertness and tendency to stay awake or fall asleep at inappropriate times). [ Time Frame: throughout study ]

Original Primary Outcome Measures ^ICMJE

Sleep Latency as measured by the Maintenance of Wakefulness test (this test evaluates alertness and tendency to stay awake or fall asleep at inappropriate times).

Change History

Complete list of historical versions of study NCT00366080 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency and severity of cataplexy attacks Severity of nocturnal disease symptoms Sleep Evaluation Scales Improvement scales Safety & Tolerability [ Time Frame: throughout study ]

Original Secondary Outcome Measures ^ICMJE

Frequency and severity of cataplexy attacks
Severity of nocturnal disease symptoms
Sleep Evaluation Scales
Improvement scales
Safety & Tolerability

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

Official Title ^ICMJE

An Open Label, Dose Escalation Study With A Double Blind Randomised Placebo Controlled Withdrawal To Examine The Effects Of The Histamine H3 Antagonist GSK189254 In Patients With Narcolepsy.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Narcolepsy

Intervention ^ICMJE

Drug: GSK189254

Other Name: GSK189254

Study Arm (s)

Not Provided

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

Terminated

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany, Netherlands, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00366080

Other Study ID Numbers ^ICMJE

H3A106104

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MA, PhD, MRCP, MFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2011

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

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