Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

Status:	Completed
Conditions:	Insomnia Sleep Studies
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	65 - Any
Updated:	4/21/2016
Start Date:	December 2007
End Date:	May 2008

Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia

A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and
tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with
primary insomnia.

Inclusion Criteria:

- Elderly subjects (> 64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

- History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental
Disorders IV (DSM-IV) axis I disorder other than primary insomnia.

- Sleep apnea, or restless legs syndrome.

- Daytime napping of more than 1 hour per day.

- Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2
years prior to the screening visit.

- Unwillingness to refrain from drugs, over-the-counter or herbal medication having an
effect on sleep or behavior.

We found this trial at

sites

California Clinical Trials Medical Group, Inc.

San Diego, California 92123

from

San Diego, CA