Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Narcolepsy

Treatments: Drug: GSK189254

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366080

H3A106104

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind