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

Purpose

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.

Condition	Intervention	Phase
Chronic Primary Insomnia	Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo Drug: ACT-078573 and matching placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Further study details as provided by Midnight Pharma, LLC:

Primary Outcome Measures:

Mean Wake Time After Sleep Onset (WASO) [ Time Frame: 2 treatment nights ] [ Designated as safety issue: No ]
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:

Mean Total Sleep Time (TST) [ Time Frame: 2 treatment nights ] [ Designated as safety issue: No ]
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).


Enrollment:	112
Study Start Date:	December 2007
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ABECD 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: BCADE 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: CDBEA 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: DECAB 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: EADBC 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: DCEBA 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: EDACB 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: AEBDC 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: BACED 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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
Experimental: CBDAE 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo	Drug: 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


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606593

Locations


United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, California
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States, 90048
Pacific Sleep Medicine Services, Inc.
San Diego, California, United States, 92121
California Clinical Trials Medical Group, Inc.
San Diego, California, United States, 92123
United States, Florida
PAB Clinical Research
Brandon, Florida, United States, 33511
Miami Research Associates
Miami, Florida, United States, 33173
OmniTrials
Naples, Florida, United States, 34110
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Neurotrials Research, Inc.
Atlanta, Georgia, United States, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Community Research
Crestview Hills, Kentucky, United States, 41017
United States, Michigan
Clinical Neurophysiology Services, P.C.
Troy, Michigan, United States, 48098
United States, Missouri
Sleep Disorders & Research Center
Chesterfield, Missouri, United States, 63017
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45227
Cleveland Clinic Health Systems
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Sleep Disorders Center
Columbia, South Carolina, United States, 29201
United States, Texas
Sleep Medicine Associates P.A.
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Midnight Pharma, LLC

Investigators


Principal Investigator:	James K. Walsh, PhD	Sleep Medicine and Research Center

More Information


Responsible Party:	Midnight Pharma, LLC
ClinicalTrials.gov Identifier:	NCT00606593 History of Changes
Other Study ID Numbers:	AC-057A201
Study First Received:	January 4, 2008
Results First Received:	December 21, 2012
Last Updated:	February 11, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Midnight Pharma, LLC:


insomnia elderly sleeplessness

Additional relevant MeSH terms:


Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias	Sleep Wake Disorders Nervous System Diseases Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016