Almorexant in Primary Insomnia
- Registration Number
- NCT00640848
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 almorexant - 2 almorexant - 5 almorexant - 3 almorexant - 4 almorexant -
- Primary Outcome Measures
Name Time Method Sleep efficiency (%) assessed by PSG (polysomnography) Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (27)
The Siesta Group
🇦🇹Vienna, Austria
Medical University of Vienna, University Clinic of Psychiatrie
🇦🇹Vienna, Austria
Skogby Sleep Clinic
🇫🇮Espoo, Finland
Technion Sleep Medicine Center, Rambam Medical Center
🇮🇱Haifa, Israel
Glostrup University Hospital Department of Sleep Medicine
🇩🇰Glostrup, Denmark
Department of Internal Medicine, Center for Sleep Medicine
🇩🇪Berlin, Germany
Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
🇩🇪Freiburg, Germany
Medical University of Innsbruck, Dept. of Neurology Sleep Disorder Unit
🇦🇹Innsbruck, Austria
Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie and Psychotherapie
🇩🇪Berlin, Germany
Hospital de la Ribera
🇪🇸Alzira, Spain
University Hospital Zurich (USZ), Neurology Polyclinic, Center for Sleep Medicine
🇨🇭Zurich, Switzerland
St Hedwig-Krankenhaus, Akademisches Lehrkrankenhaus der Charite
🇩🇪Berlin, Germany
Sleep Research Unit, Dentalia, University of Turku
🇫🇮Turku, Finland
Skaraborg Hospital, Sleep Medicine Unit, Department of Neurorehabilitation
🇸🇪Skoevde, Sweden
The Edinburgh Sleep Centre
🇬🇧Edinburgh, United Kingdom
Universitatsklinikum Giessen und Marburg, Standort Marburg, Nervenklinik
🇩🇪Marburg, Germany
Medisch Centrum Haaglanden-Westeinde Ziekenhuis, Slaapcentrum (Holland Sleep Research)
🇳🇱Den Haag, Netherlands
SOMNIBENE Institut fur Medzinische Forschung und Schlafmedizin
🇩🇪Schwerin, Germany
Psychiatric University Clinics (UPK) Basel, Dept. for Depression Research, Sleep Medicine and Neurophysiology
🇨🇭Basel, Switzerland
Hospital de la Santa Crue/Sant Pau, Institut de Recerca
🇪🇸Barcelona, Spain
Scan Sleep
🇩🇰Copenhagen, Denmark
Uppsala Akademiska Hospital, Sleep Disorder Unit
🇸🇪Uppsala, Sweden
St. Valentinushaus Klinik fur Psychiatrie und Psychotherapie
🇩🇪Kiedrich, Germany
Klinik und Poliklinik fur Psychiatrie, Psychosomatik und Psychotherapie der Universitat am Bezirsklinikum
🇩🇪Regensburg, Germany
Medical University of Vienna, Clinic of Neurology
🇦🇹Vienna, Austria
Assuta Medical Centers
🇮🇱Petah Tikva, Israel
Medical Director, The London Sleep Centre
🇬🇧London, United Kingdom