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

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ClinicalTrials.gov Identifier: NCT00606593
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Midnight Pharma, LLC

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).



Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Midnight Pharma, LLC
Investigators
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Principal Investigator: James K. Walsh, PhD Sleep Medicine and Research Center
More Information
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Responsible Party: Midnight Pharma, LLC
ClinicalTrials.gov Identifier: NCT00606593    
Other Study ID Numbers: AC-057A201
First Posted: February 4, 2008    Key Record Dates
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:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders