Almorexant in Primary Insomnia (Insomnia)

February 11, 2016 updated by: Midnight Pharma, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medical University of Innsbruck, Dept. of Neurology Sleep Disorder Unit
      • Vienna, Austria
        • Medical University of Vienna, Clinic of Neurology
      • Vienna, Austria
        • Medical University of Vienna, University Clinic of Psychiatrie
      • Vienna, Austria
        • The Siesta Group
  • Denmark
      • Copenhagen, Denmark
        • Scan Sleep
      • Glostrup, Denmark
        • Glostrup University Hospital Department of Sleep Medicine
  • Finland
      • Espoo, Finland
        • Skogby Sleep Clinic
      • Turku, Finland
        • Sleep Research Unit, Dentalia, University of Turku
  • Germany
      • Berlin, Germany
        • 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
      • Freiburg, Germany
        • Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
      • Kiedrich, Germany
        • St. Valentinushaus Klinik fur Psychiatrie und Psychotherapie
      • Marburg, Germany
        • Universitatsklinikum Giessen und Marburg, Standort Marburg, Nervenklinik
      • Regensburg, Germany
        • Klinik und Poliklinik fur Psychiatrie, Psychosomatik und Psychotherapie der Universitat am Bezirsklinikum
      • Schwerin, Germany
        • SOMNIBENE Institut fur Medzinische Forschung und Schlafmedizin
  • Israel
      • Haifa, Israel
        • Technion Sleep Medicine Center, Rambam Medical Center
      • Petah Tikva, Israel
        • Assuta Medical Centers
  • Netherlands
      • Den Haag, Netherlands
        • Medisch Centrum Haaglanden-Westeinde Ziekenhuis, Slaapcentrum (Holland Sleep Research)
  • Spain
      • Alzira, Spain
        • Hospital de La Ribera
      • Barcelona, Spain
        • Hospital de la Santa Crue/Sant Pau, Institut de Recerca
  • Sweden
      • Skoevde, Sweden
        • Skaraborg Hospital, Sleep Medicine Unit, Department of Neurorehabilitation
      • Uppsala, Sweden
        • Uppsala Akademiska Hospital, Sleep Disorder Unit
  • Switzerland
      • Basel, Switzerland
        • Psychiatric University Clinics (UPK) Basel, Dept. for Depression Research, Sleep Medicine and Neurophysiology
      • Zurich, Switzerland
        • University Hospital Zurich (USZ), Neurology Polyclinic, Center for Sleep Medicine
  • United Kingdom
      • Edinburgh, United Kingdom
        • The Edinburgh Sleep Centre
      • London, United Kingdom
        • Medical Director, The London Sleep Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Names:
  • ACT-078573
Experimental: 2
Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Names:
  • ACT-078573
Experimental: 3
Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Names:
  • ACT-078573
Experimental: 4
Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Names:
  • ACT-078573
Experimental: 5
Drug: almorexant
1 dose of 400 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 200 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 100 mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 50 mg mg in two treatment sequences
Other Names:
  • ACT-078573
Drug: almorexant
1 dose of 1000 mg in two treatment sequences
Other Names:
  • ACT-078573

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time from start of recording to the beginning of the first continuous 20 epochs of non-wake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midnight Pharma, LLC

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-057-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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