Almorexant in Adult Subjects With Chronic Primary Insomnia - Full Text View

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00608985

Purpose

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of 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:

Drug Information available for: Zolpidem Zolpidem tartrate

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Change from Baseline to Day 1&2 in WASO [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]
Change from Baseline to Day 15&16 in WASO [ Time Frame: From baseline to Day 15&16 ] [ Designated as safety issue: No ]
Change from Baseline to Week 1&2 in the self-reported WASO. [ Time Frame: From baseline to Week 1&2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline to Day 1&2 in LPS [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]
Change from Baseline to Day 15&16 in LPS [ Time Frame: From baseline to Day 15&16 ] [ Designated as safety issue: No ]
Change from Baseline to Week 1&2 in sLSO [ Time Frame: From baseline to Week 1&2 ] [ Designated as safety issue: No ]

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 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

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:	Sara Mangialaio, MD, Actelion
ClinicalTrials.gov Identifier:	NCT00608985 History of Changes
Other Study ID Numbers:	AC-057A301
Study First Received:	January 11, 2008
Last Updated:	February 3, 2010
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 - French Health Products Safety Agency 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 May 24, 2012