Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
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Purpose
| 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 Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, 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 |
- Mean Wake Time After Sleep Onset (WASO) [ Time Frame: 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).
- Mean Total Sleep Time (TST) [ Time Frame: 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).
| 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606593
| 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 | |
| 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 |
| First Submitted: | January 4, 2008 |
| First Posted: | February 4, 2008 |
| Results First Submitted: | December 21, 2012 |
| Results First Posted: | March 11, 2013 |
| Last Update Posted: | March 14, 2016 |
| Last Verified: | February 2016 |
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 |