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InsomniaPhase 1InsomniaNCT00640848

Almorexant in Primary Insomnia

A Phase 1 study testing almorexant in people with Insomnia and Primary Insomnia, run by Midnight Pharma, LLC at 27 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Insomnia, Primary Insomnia
What is being tested?
almorexant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
27 sitesin 10 countries
Study dates
May 2006to Sep 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

27 sites in 10 countries.

27 sites in 10 countries

Germany8 sites

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

    Berlin

  • Department of Internal Medicine, Center for Sleep Medicine

    Berlin

  • St Hedwig-Krankenhaus, Akademisches Lehrkrankenhaus der Charite

    Berlin

  • Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

    Freiburg im Breisgau

  • St. Valentinushaus Klinik fur Psychiatrie und Psychotherapie

    Kiedrich

  • Universitatsklinikum Giessen und Marburg, Standort Marburg, Nervenklinik

    Marburg

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

    Regensburg

  • SOMNIBENE Institut fur Medzinische Forschung und Schlafmedizin

    Schwerin

Other trials in Germany

Austria4 sites

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

    Innsbruck

  • Medical University of Vienna, Clinic of Neurology

    Vienna

  • Medical University of Vienna, University Clinic of Psychiatrie

    Vienna

  • The Siesta Group

    Vienna

Other trials in Austria

Denmark2 sites

  • Scan Sleep

    Copenhagen

  • Glostrup University Hospital Department of Sleep Medicine

    Glostrup Municipality

Other trials in Denmark

Finland2 sites

  • Skogby Sleep Clinic

    Espoo

  • Sleep Research Unit, Dentalia, University of Turku

    Turku

Other trials in Finland

Israel2 sites

  • Technion Sleep Medicine Center, Rambam Medical Center

    Haifa

  • Assuta Medical Centers

    Petah Tikva

Other trials in Israel

Spain2 sites

  • Hospital de la Ribera

    Alzira

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

    Barcelona

Other trials in Spain

Sweden2 sites

  • Skaraborg Hospital, Sleep Medicine Unit, Department of Neurorehabilitation

    Skövde

  • Uppsala Akademiska Hospital, Sleep Disorder Unit

    Uppsala

Other trials in Sweden

Switzerland2 sites

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

    Basel

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

    Zurich

Other trials in Switzerland

United Kingdom2 sites

  • The Edinburgh Sleep Centre

    Edinburgh

  • Medical Director, The London Sleep Centre

    London

Other trials in United Kingdom

Netherlands1 site

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

    The Hague

Other trials in Netherlands

About this study

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

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.

Being tested
almorexant
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • almorexantDrug

    Also called ACT-078573

    1 dose of 400 mg in two treatment sequences

  • almorexantDrug

    Also called ACT-078573

    1 dose of 200 mg in two treatment sequences

  • almorexantDrug

    Also called ACT-078573

    1 dose of 100 mg in two treatment sequences

  • almorexantDrug

    Also called ACT-078573

    1 dose of 50 mg mg in two treatment sequences

  • almorexantDrug

    Also called ACT-078573

    1 dose of 1000 mg in two treatment sequences

Study groups in NCT00640848
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: almorexant
2ExperimentalNot described
Receives: Drug: almorexant
3ExperimentalNot described
Receives: Drug: almorexant
4ExperimentalNot described
Receives: Drug: almorexant
5ExperimentalNot described
Receives: Drug: almorexant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep efficiency (%) assessed by PSG (polysomnography)

    Measured: Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on)

Secondary outcomes (1)

  1. LPS (Latency to Persistent Sleep) [min] assessed by PSG (polysomnography)

    Measured: Time from start of recording to the beginning of the first continuous 20 epochs of non-wake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2008 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00640848
Sponsor's protocol ID
AC-057-103
Acronym
Insomnia
Status last verified
Feb 2016
First submitted
18 Mar 2008
Last updated
12 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22549286

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing almorexant in people with Insomnia and Primary Insomnia, run by Midnight Pharma, LLC at 27 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, Austria, Denmark, Finland, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep efficiency (%) assessed by PSG (polysomnography) (time frame: Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00640848, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.

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