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Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia - Full Text View - ClinicalTrials.gov

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    Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (RESTORA 1)

    The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT00608985 Recruitment Status : Completed First Posted : February 6, 2008 Results First Posted : February 7, 2013 Last Update Posted : March 14, 2016 Sponsor: Midnight Pharma, LLC Information provided by (Responsible Party): Midnight Pharma, LLC
    Study Description Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Brief Summary: A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
    Condition or disease Intervention/treatment Phase Primary Insomnia Drug: almorexant Drug: Placebo Drug: zolpidem Phase 3
    Study Design Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

    Layout table for study information Study Type : Interventional  (Clinical Trial) Actual Enrollment : 709 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia Study Start Date : March 2008 Actual Primary Completion Date : September 2009 Actual Study Completion Date : November 2009

    Resource links provided by the National Library of Medicine

    Drug Information available for: Zolpidem U.S. FDA Resources
    Arms and Interventions Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

    Arm Intervention/treatment Experimental: 1 almorexant 200 mg Drug: almorexant 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
    Experimental: 2 almorexant 100 mg Drug: almorexant 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
    Placebo Comparator: 3 Placebo Drug: Placebo 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
    Active Comparator: 4 zolpidem 10 mg Drug: zolpidem 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated


    Outcome Measures Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
    Primary Outcome Measures :
    1. Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) [ Time Frame: From baseline to Day 1&2 ]

      WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

      For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16


    2. Change From Baseline to Day 15&16 in WASO [ Time Frame: From baseline to Day 15&16 ]

      WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

      For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16


    3. Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) [ Time Frame: From baseline to Week 1&2 ]sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2

    Secondary Outcome Measures :
    1. Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) [ Time Frame: From baseline to Day 1&2 ]LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
    2. Change From Baseline to Day 15&16 in LPS [ Time Frame: From baseline to Day 15&16 ]LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
    3. Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) [ Time Frame: From baseline to Week 1&2 ]sLSO was the self-reported time to fall asleep as reported in the sleep diary

    Eligibility Criteria Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

    Information from the National Library of Medicine

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    Layout table for eligibility information Ages Eligible for Study: 18 Years to 64 Years   (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria

    Inclusion Criteria:

    • Adult subjects (18-64 years) with a diagnosis of primary insomnia.

    Exclusion Criteria:

    • History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (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 Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
    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): NCT00608985


      Show 91 Study Locations
    Sponsors and Collaborators Midnight Pharma, LLC Investigators Layout table for investigator information Study Chair: Raymond Cluydts, Dr. Cognitive and Biological Psychology, University of Brussels More Information Go to  Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
    Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.
    Layout table for additonal information Responsible Party: Midnight Pharma, LLC ClinicalTrials.gov Identifier: NCT00608985     History of Changes Other Study ID Numbers: AC-057A301
    First Posted: February 6, 2008    Key Record Dates Results First Posted: February 7, 2013 Last Update Posted: March 14, 2016 Last Verified: February 2016 Keywords provided by Midnight Pharma, LLC: sleeplessness
    orexin receptor antagonist
    almorexant
    insomnia
    Additional relevant MeSH terms: Layout table for MeSH terms Sleep Initiation and Maintenance Disorders
    Sleep Disorders, Intrinsic
    Dyssomnias
    Sleep Wake Disorders
    Nervous System Diseases
    Mental Disorders
    Zolpidem
    Sleep Aids, Pharmaceutical
    Hypnotics and Sedatives
    Central Nervous System Depressants
    Physiological Effects of Drugs
    GABA-A Receptor Agonists
    GABA Agonists
    GABA Agents
    Neurotransmitter Agents
    Molecular Mechanisms of Pharmacological Action


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