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

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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:
Information provided by (Responsible Party):
Midnight Pharma, LLC

Study Description
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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
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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

Arms and Interventions
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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
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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
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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
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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): NCT00608985


Locations
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Sponsors and Collaborators
Midnight Pharma, LLC
Investigators
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Study Chair: Raymond Cluydts, Dr. Cognitive and Biological Psychology, University of Brussels
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Midnight Pharma, LLC
ClinicalTrials.gov Identifier: NCT00608985    
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:
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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