NCT00640848

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Geographic Reach
10 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

March 18, 2008

Last Update Submit

February 11, 2016

Conditions

InsomniaPrimary 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
Drug: almorexant

5

EXPERIMENTAL
Drug: almorexant

Interventions

almorexantDRUG

1 dose of 400 mg in two treatment sequences

Also known as: ACT-078573
1

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.
  • Reliable methods of contraception are:
  • Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
  • Intra-uterine devices.
  • Oral, injectable, implantable or transdermal contraceptives only in combination with a barrier method.
  • Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
  • Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
  • Body mass index (BMI) between 18 and 30 kg/m2 (limits included) at screening visit.
  • lead ECG without clinically relevant abnormalities at screening visit.
  • Hematology and biochemistry test results not deviating from the normal range to a clinically relevant extent at screening visit and following the screening/adaptation night.
  • Primary insomnia by DSM-IV-TR criteria based on medical history and the assessments performed at screening visit.
  • History of the following for at least 3 months prior to the screening visit:
  • Usual reported subjective total sleep time (TST) 3 - 6 hours.
  • Usual sleep disturbance with a subjective sleep onset latency of \> 30 min.
  • +5 more criteria

You may not qualify if:

  • Symptom assessment questionnaire (SBB) for diagnosis of apnea resulting in a score \> 2 at screening visit.
  • Zung self-rating depression scale (SDS) and/or Zung self-rating anxiety scale (SAS) resulting in a raw score ≥ 50 at screening visit.
  • Restless legs syndrome and/or meeting all four essential diagnostic criteria for RLS (see Appendix 10).
  • Insomnia due to sleep apnea or periodic limb movement disorder as assessed by PSG at screening/adaptation night:
  • apnea/hypopnea index (AHI) \> 10/h
  • periodic limb movement arousal index \> 10/h
  • Major depressive disorder, severe psychosis, or significant anxiety disorder.
  • Pregnancy or breast-feeding.
  • Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening visit.
  • Within the 2-month period prior to the screening visit, clinical evidence of alcoholism or drug abuse.
  • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or a disease which may affect the pharmacokinetics of the study drug.
  • Treatment with strong inhibitors of CYP3A4 (e.g., azole derivatives, ritonavir, clarithromycin) within 1 week prior to the screening/adaptation PSG night and up to the end of treatment period 2.
  • Excessive caffeine consumption (regular caffeine consumption of \> 7 units per day).
  • Night shift workers.
  • Known hypersensitivity to any excipients of the drug formulation.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

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

Innsbruck, Austria

Location

Medical University of Vienna, Clinic of Neurology

Vienna, Austria

Location

Medical University of Vienna, University Clinic of Psychiatrie

Vienna, Austria

Location

The Siesta Group

Vienna, Austria

Location

Scan Sleep

Copenhagen, Denmark

Location

Glostrup University Hospital Department of Sleep Medicine

Glostrup Municipality, Denmark

Location

Skogby Sleep Clinic

Espoo, Finland

Location

Sleep Research Unit, Dentalia, University of Turku

Turku, Finland

Location

Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie and Psychotherapie

Berlin, Germany

Location

Department of Internal Medicine, Center for Sleep Medicine

Berlin, Germany

Location

St Hedwig-Krankenhaus, Akademisches Lehrkrankenhaus der Charite

Berlin, Germany

Location

Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

Freiburg im Breisgau, Germany

Location

St. Valentinushaus Klinik fur Psychiatrie und Psychotherapie

Kiedrich, Germany

Location

Universitatsklinikum Giessen und Marburg, Standort Marburg, Nervenklinik

Marburg, Germany

Location

Klinik und Poliklinik fur Psychiatrie, Psychosomatik und Psychotherapie der Universitat am Bezirsklinikum

Regensburg, Germany

Location

SOMNIBENE Institut fur Medzinische Forschung und Schlafmedizin

Schwerin, Germany

Location

Technion Sleep Medicine Center, Rambam Medical Center

Haifa, Israel

Location

Assuta Medical Centers

Petah Tikva, Israel

Location

Medisch Centrum Haaglanden-Westeinde Ziekenhuis, Slaapcentrum (Holland Sleep Research)

The Hague, Netherlands

Location

Hospital de la Ribera

Alzira, Spain

Location

Hospital de la Santa Crue/Sant Pau, Institut de Recerca

Barcelona, Spain

Location

Skaraborg Hospital, Sleep Medicine Unit, Department of Neurorehabilitation

Skövde, Sweden

Location

Uppsala Akademiska Hospital, Sleep Disorder Unit

Uppsala, Sweden

Location

Psychiatric University Clinics (UPK) Basel, Dept. for Depression Research, Sleep Medicine and Neurophysiology

Basel, Switzerland

Location

University Hospital Zurich (USZ), Neurology Polyclinic, Center for Sleep Medicine

Zurich, Switzerland

Location

The Edinburgh Sleep Centre

Edinburgh, United Kingdom

Location

Medical Director, The London Sleep Centre

London, United Kingdom

Location

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

  • Georg Dorffner, Prof. Dr.

    The Siesta Group

    PRINCIPAL INVESTIGATOR

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 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

AU(4)CH(2)DE(8)IL(2)GB(2)ES(2)NL(1)SE(2)FI(2)DK(2)