Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
- Conditions
- Chronic Primary Insomnia
- Interventions
- Drug: ACT-078573 and matching placeboDrug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo
- Registration Number
- NCT00606593
- Lead Sponsor
- Midnight Pharma, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Elderly subjects (> 64 years) with a diagnosis of primary insomnia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CDBEA ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo DECAB ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo CBDAE ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo BCADE ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo DCEBA ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo EDACB ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo AEBDC ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo ABECD 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 ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo BACED ACT-078573 and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
- Primary Outcome Measures
Name Time Method Mean Wake Time After Sleep Onset (WASO) 2 treatment nights 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).
- Secondary Outcome Measures
Name Time Method Mean Total Sleep Time (TST) 2 treatment nights TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by 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 TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).
Trial Locations
- Locations (20)
Sleep Medicine Associates P.A.
🇺🇸Dallas, Texas, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
OmniTrials
🇺🇸Naples, Florida, United States
Sleep Disorders Center of Georgia
🇺🇸Atlanta, Georgia, United States
Broward Research Group & Sleep-Wake Disorders Center of South Florida
🇺🇸Pembroke Pines, Florida, United States
Neurotrials Research, Inc.
🇺🇸Atlanta, Georgia, 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
Sleep Disorders Center
🇺🇸Columbia, South Carolina, United States
Central Arkansas Research
🇺🇸Hot Springs, Arkansas, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Pacific Sleep Medicine Services, Inc.
🇺🇸San Diego, California, United States
California Clinical Trials Medical Group, Inc.
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, 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