Trials Sponsors Conditions Drugs Pricing

Conditions

Insomnia Primary Insomnia

Outcome Measures

Primary Outcomes (1)

Sleep efficiency (%) assessed by PSG (polysomnography)
Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on)

Secondary Outcomes (1)

LPS (Latency to Persistent Sleep) [min] assessed by PSG (polysomnography)
Time from start of recording to the beginning of the first continuous 20 epochs of non-wake

Study Arms (5)

1

EXPERIMENTAL

Drug: almorexant

2

EXPERIMENTAL

Drug: almorexant

3

EXPERIMENTAL

Drug: almorexant

4

EXPERIMENTAL

Interventions

almorexantDrug

1 dose of 400 mg in two treatment sequences

Also known as: ACT-078573

almorexantDrug

1 dose of 200 mg in two treatment sequences

Also known as: ACT-078573

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men or women 18 - 65 years of age (inclusive).
Women of childbearing potential must have a negative urine pregnancy test at the screening visit, the screening adaptation night, and pre-treatment and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.

Sponsors & Collaborators

Midnight Pharma, LLC
Industrylead

Study Sites (27)

Medical University of Innsbruck, Dept. of Neurology Sleep Disorder Unit

Innsbruck, Austria

Medical University of Vienna, Clinic of Neurology

Vienna, Austria

Medical University of Vienna, University Clinic of Psychiatrie

Vienna, Austria

The Siesta Group

Vienna, Austria

Scan Sleep

Copenhagen, Denmark

Glostrup University Hospital Department of Sleep Medicine

Glostrup Municipality, Denmark

Skogby Sleep Clinic

Espoo, Finland

Related Publications (1)

Hoever P, Dorffner G, Benes H, Penzel T, Danker-Hopfe H, Barbanoj MJ, Pillar G, Saletu B, Polo O, Kunz D, Zeitlhofer J, Berg S, Partinen M, Bassetti CL, Hogl B, Ebrahim IO, Holsboer-Trachsler E, Bengtsson H, Peker Y, Hemmeter UM, Chiossi E, Hajak G, Dingemanse J. Orexin receptor antagonism, a new sleep-enabling paradigm: a proof-of-concept clinical trial. Clin Pharmacol Ther. 2012 Jun;91(6):975-85. doi: 10.1038/clpt.2011.370.
PMID: 22549286DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

almorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

Jasper Dingemanse, PhD
Actelion
STUDY DIRECTOR
Eleornora Chiossi, MSc
Actelion
STUDY DIRECTOR
Petra Hoever, MSc
Actelion
STUDY DIRECTOR
Fabrice Kramer, MD
Actelion
STUDY DIRECTOR

Enrollment

161 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Almorexant in Primary Insomnia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (5)

1

2

3

4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

5

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (5)

1

2

3

4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

5

You may not qualify if:

Source record

Locations