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

Phase 2

Completed

• Conditions: Chronic Primary Insomnia
• Interventions: Drug: ACT-078573 and matching placebo; Drug: 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

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-04
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Disposition First Submitted: 2010-02-11
• Disposition First Submitted QC: 2010-02-11
• Disposition First Posted: 2010-02-15
• Results First Submitted: 2012-12-21
• Results First Submitted QC: 2013-02-06
• Results First Posted: 2013-03-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

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)

Central Arkansas Research; 🇺🇸 Hot Springs, Arkansas, 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

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