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

August 17, 2006
March 10, 2011
November 2006
Not Provided
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 ]
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).
Complete list of historical versions of study NCT00366080 on ClinicalTrials.gov Archive Site
Frequency and severity of cataplexy attacks Severity of nocturnal disease symptoms Sleep Evaluation Scales Improvement scales Safety & Tolerability [ Time Frame: throughout study ]
  • Frequency and severity of cataplexy attacks
  • Severity of nocturnal disease symptoms
  • Sleep Evaluation Scales
  • Improvement scales
  • Safety & Tolerability
Not Provided
Not Provided
 
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Narcolepsy
Drug: GSK189254
Other Name: GSK189254
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
Not Provided
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Austria,   United Kingdom,   Netherlands,   Spain
 
NCT00366080
H3A106104
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MA, PhD, MRCP, MFPM GlaxoSmithKline
GlaxoSmithKline
March 2011

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