Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
NCT ID: NCT00606593
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2007-12-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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ABECD
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo
5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BCADE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CDBEA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DECAB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EADBC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DCEBA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EDACB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
AEBDC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BACED
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CBDAE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Interventions
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo
5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
ACT-078573 and matching placebo
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Midnight Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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James K. Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Sleep Medicine and Research Center
Locations
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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
Countries
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Other Identifiers
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AC-057A201
Identifier Type: -
Identifier Source: org_study_id
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