Almorexant in Adult Subjects With Chronic Primary Insomnia - Tabular View

Tracking Information

First Received Date ^ICMJE

January 11, 2008

Last Updated Date

February 3, 2010

Start Date ^ICMJE

March 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change in wake after sleep onset (WASO) [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]
Change in latency to persistent sleep (LPS) [ Time Frame: From baseline to Day 1&2 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00608985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Almorexant in Adult Subjects With Chronic Primary Insomnia

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Chronic Primary Insomnia

Intervention ^ICMJE

Drug: almorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
Drug: almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
Drug: Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
Drug: zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Study Arms / Comparison Groups

1: Experimental
almorexant 200 mg

Intervention: Drug: almorexant
2: Experimental
almorexant 100 mg

Intervention: Drug: almorexant
3: Placebo Comparator
Placebo

Intervention: Drug: Placebo
4: Active Comparator
zolpidem 10 mg

Intervention: Drug: zolpidem

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

709

Completion Date

November 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00608985

Responsible Party

Sara Mangialaio, MD, Actelion

Study ID Numbers ^ICMJE

AC-057A301

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Actelion

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP