Almorexant in Primary Insomnia (Insomnia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640848
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : February 12, 2016
Information provided by:
Midnight Pharma, LLC

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.

Condition or disease Intervention/treatment Phase
Insomnia Primary Insomnia Drug: almorexant Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Multiple-stage, Double-blind, Randomized, Placebo-controlled, Two-way Crossover, Single-dose Study to Investigate the Effects of ACT-078573 on Sleep Measured by Polysomnography in Patients With Primary Insomnia
Study Start Date : May 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: 1 Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Name: ACT-078573

Experimental: 2 Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Name: ACT-078573

Experimental: 3 Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Name: ACT-078573

Experimental: 4 Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Name: ACT-078573

Experimental: 5 Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Name: ACT-078573

Primary Outcome Measures :
  1. Sleep efficiency (%) assessed by PSG (polysomnography) [ Time Frame: Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on) ]

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 12-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.
    • Daytime complaints associated with poor sleep (e.g., fatigue, irritability, difficulty concentrating).
  • Polysomnography (PSG) at screening/adaptation night confirming TST < 6 h and LPS ≥ 20 min.
  • Willingness to refrain from CNS-active drugs for 5 half-lives of the respective drug (but at least 1 week) prior to the screening/adaptation night and up to the end of treatment period 2. The usage of short-acting hypnotics (defined as hypnotics with a half-life of up to and including 10 hours) is allowed up to 48 hours prior to each PSG night, i.e., prior to the screening/adaptation night and prior to the treatment PSG nights.
  • Urine drug test negative for barbiturates, cannabinoids, amphetamines, and cocaine at screening visit 1, screening/adaptation PSG night and pre-treatment. Urine drug test negative for benzodiazepines and opiates at screening/adaptation PSG night and pre-treatment.
  • Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

  • 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.
  • Planned treatment or treatment with another investigational drug within 1 month prior to randomization and up to the end of treatment period 2.
  • Known concomitant life-threatening disease with a life expectancy < 24 months.
  • Unstable medical abnormality, significant medical disorder or acute illness.
  • Recruitment of the same patient twice to the same dose level. Patients may be recruited to a lower dose level, provided that there are at least 28 days between last study drug administration and screening/adaptation PSG night.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00640848

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, Denmark
Skogby Sleep Clinic
Espoo, Finland
Sleep Research Unit, Dentalia, University of Turku
Turku, Finland
Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie and Psychotherapie
Berlin, Germany
Department of Internal Medicine, Center for Sleep Medicine
Berlin, Germany
St Hedwig-Krankenhaus, Akademisches Lehrkrankenhaus der Charite
Berlin, Germany
Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
Freiburg, Germany
St. Valentinushaus Klinik fur Psychiatrie und Psychotherapie
Kiedrich, Germany
Universitatsklinikum Giessen und Marburg, Standort Marburg, Nervenklinik
Marburg, Germany
Klinik und Poliklinik fur Psychiatrie, Psychosomatik und Psychotherapie der Universitat am Bezirsklinikum
Regensburg, Germany
SOMNIBENE Institut fur Medzinische Forschung und Schlafmedizin
Schwerin, Germany
Technion Sleep Medicine Center, Rambam Medical Center
Haifa, Israel
Assuta Medical Centers
Petah Tikva, Israel
Medisch Centrum Haaglanden-Westeinde Ziekenhuis, Slaapcentrum (Holland Sleep Research)
Den Haag, Netherlands
Hospital de la Ribera
Alzira, Spain
Hospital de la Santa Crue/Sant Pau, Institut de Recerca
Barcelona, Spain
Skaraborg Hospital, Sleep Medicine Unit, Department of Neurorehabilitation
Skoevde, Sweden
Uppsala Akademiska Hospital, Sleep Disorder Unit
Uppsala, Sweden
Psychiatric University Clinics (UPK) Basel, Dept. for Depression Research, Sleep Medicine and Neurophysiology
Basel, Switzerland
University Hospital Zurich (USZ), Neurology Polyclinic, Center for Sleep Medicine
Zurich, Switzerland
United Kingdom
The Edinburgh Sleep Centre
Edinburgh, United Kingdom
Medical Director, The London Sleep Centre
London, United Kingdom
Sponsors and Collaborators
Midnight Pharma, LLC
Study Director: Jasper Dingemanse, PhD Actelion
Study Director: Eleornora Chiossi, MSc Actelion
Study Director: Petra Hoever, MSc Actelion
Study Director: Fabrice Kramer, MD Actelion
Principal Investigator: Georg Dorffner, Prof. Dr. The Siesta Group

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jasper Dingemanse, Actelion Identifier: NCT00640848     History of Changes
Other Study ID Numbers: AC-057-103
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders