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
  Purpose

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


Condition Intervention Phase
Narcolepsy
Drug: GSK189254
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 70
Study Start Date: November 2006
Intervention Details:
    Drug: GSK189254
    Other Name: GSK189254
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366080

Locations
Austria
GSK Investigational Site
Innsbruck, Austria, A-6020
GSK Investigational Site
Vienna, Austria, A-1190
Germany
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Schwalmstadt, Hessen, Germany, 34613
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44789
GSK Investigational Site
Berlin, Germany, 14050
Netherlands
GSK Investigational Site
Leiden, Netherlands, 2333 CL
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08035
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB3 8RE
GSK Investigational Site
Edinburgh, United Kingdom, EH3 6HP
GSK Investigational Site
London, United Kingdom, W1G 6BF
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MA, PhD, MRCP, MFPM GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00366080     History of Changes
Other Study ID Numbers: H3A106104
Study First Received: August 17, 2006
Last Updated: March 10, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
GSK189254 H3 Histamine Narcolepsy

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Histamine H3 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014