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
Sponsor study identifier
interventional
112
1 country
21
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
May 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 4, 2008
Actual (reported)February 4, 2008
Actual (reported)April 2008
Actual (reported)May 2008
Actual (reported)March 11, 2013
Actual (reported)Mean Wake Time After Sleep Onset (WASO)
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
2 treatment nights
Mean Total Sleep Time (TST)
2 treatment nights
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = 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 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
Central Arkansas Research
Hot Springs, Arkansas, 71913, United States
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, 90048, United States
Pacific Sleep Medicine Services, Inc.
San Diego, California, 92121, United States
California Clinical Trials Medical Group, Inc.
San Diego, California, 92123, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Miami Research Associates
Miami, Florida, 33173, United States
OmniTrials
Naples, Florida, 34110, United States
James K. Walsh, PhD
Sleep Medicine and Research Center
112 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2008
First Posted
February 4, 2008
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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 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 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 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 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 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 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 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 Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Pembroke Pines, Florida, 33026, United States
Neurotrials Research, Inc.
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Community Research
Crestview Hills, Kentucky, 41017, United States
Clinical Neurophysiology Services, P.C.
Troy, Michigan, 48098, United States
Sleep Disorders & Research Center
Chesterfield, Missouri, 63017, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Duke University
Durham, North Carolina, 27710, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45227, United States
Cleveland Clinic Health Systems
Cleveland, Ohio, 44195, United States
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, 73112, United States
Sleep Disorders Center
Columbia, South Carolina, 29201, United States
Sleep Medicine Associates P.A.
Dallas, Texas, 75231, United States
Primary Completion
April 2008
Actual (reported)Study Completion
May 2008
Actual (reported)Last Updated
March 14, 2016
Results First Posted
March 11, 2013
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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