To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: SB-649868; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426816

OXS107714

Details and patient eligibility

About

This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia

Enrollment: 48 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• 18-64 years of age (inclusive),
• Diagnosis of primary insomnia who have had symptoms for at least three months.

Exclusion criteria

• Any clinically significant unstable medical or surgical condition (treated or untreated).
• Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 1 patient group

Crossover population

Experimental group

Description:

All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing

Treatment:

Drug: Placebo

Drug: SB-649868