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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Primary Insomnia

In brief

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.

Key facts

Study ID

NCT00606593

Run by

Midnight Pharma, LLC

People needed

112

Starts

2007-12-01

Expected to finish

2008-05-01

Last updated by the study team

2016-03-14

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Central Arkansas Research — Hot Springs, Arkansas, United States
• Pacific Sleep Medicine Services, Inc. — Los Angeles, California, United States
• Pacific Sleep Medicine Services, Inc. — San Diego, California, United States
• California Clinical Trials Medical Group, Inc. — San Diego, California, United States
• PAB Clinical Research — Brandon, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• OmniTrials — Naples, Florida, United States
• Broward Research Group & Sleep-Wake Disorders Center of South Florida — Pembroke Pines, Florida, United States
• Neurotrials Research, Inc. — Atlanta, Georgia, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Community Research — Crestview Hills, Kentucky, United States
• Clinical Neurophysiology Services, P.C. — Troy, Michigan, United States
• Sleep Disorders & Research Center — Chesterfield, Missouri, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Duke University — Durham, North Carolina, United States
• Tri-State Sleep Disorders Center — Cincinnati, Ohio, United States
• Cleveland Clinic Health Systems — Cleveland, Ohio, United States
• Lynn Health Sciences Institute — Oklahoma City, Oklahoma, United States
• Sleep Disorders Center — Columbia, South Carolina, United States
• Sleep Medicine Associates P.A. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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