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

NCT00608985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 709

Last updated 2016-03-14

Study results available
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Summary

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

Conditions

  • Primary Insomnia

Interventions

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

Sponsors & Collaborators

  • Midnight Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Raymond Cluydts, Dr. · Cognitive and Biological Psychology, University of Brussels

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-09-30
Completion
2009-11-30

Countries

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

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608985 on ClinicalTrials.gov