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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00608985
First received: January 11, 2008
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.


Condition Intervention Phase
Chronic Primary Insomnia
Drug: almorexant
Drug: Placebo
Drug: zolpidem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]

    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


  • Change From Baseline to Day 15&16 in WASO [ Time Frame: From baseline to Day 15&16 ] [ Designated as safety issue: No ]

    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


  • Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) [ Time Frame: From baseline to Week 1&2 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]
    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

  • Change From Baseline to Day 15&16 in LPS [ Time Frame: From baseline to Day 15&16 ] [ Designated as safety issue: No ]
    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

  • Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) [ Time Frame: From baseline to Week 1&2 ] [ Designated as safety issue: No ]
    sLSO was the self-reported time to fall asleep as reported in the sleep diary


Enrollment: 709
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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: NCT00608985

  Show 91 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Goran Hajak, Prof. Klinik und Poliklinik fur Psychiatre, Psychosomatik und Psychotherapie der Universitat am Bezirksklinikum Regensburg
Study Chair: Claudio Bassetti, Prof. University Hospital Zurich (USZ), Neurology Polyclinic, Center for Sleep Medicine
Study Chair: Giora Pillar, Prof. Technion Sleep Medicine Center, Rambam Medical Center
Study Chair: Chris Idzikowski, Dr. The Edinburgh Sleep Centre
Study Chair: Emmanuel Mignot, Dr. Stanford Center for Narcolepsy
Study Chair: Jan Hedner, Prof. Sleep Laboratory Services, Sahlgrenska University Hospital
Study Chair: Raymond Cluydts, Dr. Cognitive and Biological Psychology, University of Brussels
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00608985     History of Changes
Other Study ID Numbers: AC-057A301
Study First Received: January 11, 2008
Results First Received: December 21, 2012
Last Updated: February 6, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
South Africa: Medicines Control Council
Spain: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Actelion:
insomnia
sleeplessness
almorexant
orexin receptor antagonist

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014