Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

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

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.

Conditions

Narcolepsy

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

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).

Secondary Outcome Measures:

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

Study Start

August 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 65 Years
• Genders Eligible for Study: Both

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.

Total Enrolment

70

Contact Details

• Melbourne, Victoria, 3002, Australia; Recruiting

Contact GlaxoSmithKline for more information.