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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • almorexant 200 mg
• Experimental: 2
  • almorexant 100 mg
• Placebo Comparator: 3
  • Placebo
• Active Comparator: 4
  • zolpidem 10 mg

Primary Measures

• Change in latency to persistent sleep (LPS)
  • Time Frame: From baseline to Day 1&2
    Safety Issue?: No
• Change in wake after sleep onset (WASO)
  • Time Frame: From baseline to Day 1&2
    Safety Issue?: No

Secondary Measures

• Change in LPS and WASO
  • Time Frame: From baseline to Day 15&16
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Actelion

Overall Clinical Trial Officials and Contacts

Goran Hajak, Prof. Study Chair Klinik und Poliklinik fur Psychiatre, Psychosomatik und Psychotherapie der Universitat am Bezirksklinikum Regensburg  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00608985

Study ID Number: AC-057A301

ClinicalTrials.gov Identifier: NCT00608985

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration