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Almorexant in Primary Insomnia

NCT00640848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-02-12

No results posted yet for this study

Summary

The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep efficiency and to assess the effects of different doses of ACT-078573 on other PSG parameters.

Conditions

Interventions

DRUG

almorexant

1 dose of 400 mg in two treatment sequences

DRUG

almorexant

1 dose of 200 mg in two treatment sequences

DRUG

almorexant

1 dose of 100 mg in two treatment sequences

DRUG

almorexant

1 dose of 50 mg mg in two treatment sequences

DRUG

almorexant

1 dose of 1000 mg in two treatment sequences

Sponsors & Collaborators

  • Midnight Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Jasper Dingemanse, PhD · Actelion

  • Eleornora Chiossi, MSc · Actelion

  • Petra Hoever, MSc · Actelion

  • Fabrice Kramer, MD · Actelion

  • Georg Dorffner, Prof. Dr. · The Siesta Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-08-31
Completion
2007-09-30

Countries

  • Austria
  • Denmark
  • Finland
  • Germany
  • Israel
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00640848 on ClinicalTrials.gov