Status:
TERMINATED
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Narcolepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00366080
Start Date
November 1 2006
End Date
January 1 2008
Last Update
March 10 2017
Active Locations (14)
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1
GSK Investigational Site
Innsbruck, Austria, A-6020
2
GSK Investigational Site
Vienna, Austria, A-1190
3
GSK Investigational Site
Espoo, Finland, 02980
4
GSK Investigational Site
Regensburg, Bavaria, Germany, 93053