Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
- Registration Number
- NCT00608985
- Lead Sponsor
- Midnight Pharma, LLC
- Brief Summary
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 709
- Adult subjects (18-64 years) with a diagnosis of primary insomnia.
- History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
- Sleep apnea, or restless legs syndrome.
- Daytime napping of more than 1 hour per day.
- Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
- Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo 4 zolpidem zolpidem 10 mg 1 almorexant almorexant 200 mg 2 almorexant almorexant 100 mg
- Primary Outcome Measures
Name Time Method Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) From baseline to Day 1&2 WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.
For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16Change From Baseline to Day 15&16 in WASO From baseline to Day 15&16 WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.
For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) From baseline to Week 1&2 sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1\&2
- Secondary Outcome Measures
Name Time Method Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) From baseline to Day 1&2 LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Change From Baseline to Day 15&16 in LPS From baseline to Day 15&16 LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) From baseline to Week 1&2 sLSO was the self-reported time to fall asleep as reported in the sleep diary
Trial Locations
- Locations (90)
The Woolcock Institute of Medical Research
🇦🇺Glebe, Australia
Australian Clinical Research Organisation
🇦🇺Kippa Ring, Australia
Melbourne Sleep Disorder Centre
🇦🇺Melbourne, Australia
Burnside Hospital Clinical Trials Centre
🇦🇺Toorak Gardens, Australia
Medical University of Innsbruck, Department of Neurology
🇦🇹Innsbruck, Austria
Westmead Hospital, Department of Respiratory
🇦🇺Westmead, Australia
Rudolfinerhaus
🇦🇹Vienna, Austria
Clinique Andre Vesale
🇧🇪Montigny le Tilleuil, Belgium
MHAT 'St. Marina'
🇧🇬Varna, Bulgaria
Scansleep Aps, Sovnlaegecentret
🇩🇰Arhus, Denmark
Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie
🇨🇿Trutnov, Czech Republic
Tutkimuskeskus Vitalmed
🇫🇮Helsinki, Finland
Unesta Research Center
🇫🇮Tampere, Finland
Hopital Pellegrin
🇫🇷Bordeaux, France
Service de Neurologie B, Hopital Gui de Chauliac
🇫🇷Montpellier, France
Hopital Raymond Poincare
🇫🇷Garches, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie
🇩🇪Berlin, Germany
Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
🇫🇷Paris, France
Advanced Sleep Research GmbH
🇩🇪Berlin, Germany
Federation des Pathologies du Sommeil
🇫🇷Paris, France
ClinPharm International GmbH Berlin
🇩🇪Berlin, Germany
Klinische Forschung Berlin GmbH
🇩🇪Berlin, Germany
ClinPharm International GmbH Dresden
🇩🇪Dresden, Germany
St. Hedwig-Krnkenhaus
🇩🇪Berlin, Germany
ClinPharm International GmbH Bochum
🇩🇪Bochum, Germany
ClinPharm International GmbH Chemnitz
🇩🇪Chemnitz, Germany
ClinPharm International GmbH Frankfurt
🇩🇪Frankfurt, Germany
Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
🇩🇪Freiburg, Germany
ClinPharm International GmbH Gorlitz
🇩🇪Gorlitz, Germany
Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH
🇩🇪Marburg, Germany
Klinische Forschung
🇩🇪Hamburg, Germany
ClinPharm International GmbH Leipzig
🇩🇪Leipzig, Germany
ClinPharm International GmbH Magdeburg
🇩🇪Magdeburg, Germany
ClinPharm International GmbH Potsdam
🇩🇪Potsdam, Germany
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Klinik und Poliklinik fur Psychiatre
🇩🇪Regensburg, Germany
SOMNIBENE Institut fur Medizinische
🇩🇪Schwerin, Germany
Sleep Disorder Centre, State Health Centre
ðŸ‡ðŸ‡ºBudapest, Hungary
Sleep Laboratory, Ilnd Hospital
ðŸ‡ðŸ‡ºSzeged, Hungary
Soroka University Medical Center, Unit for Sleep Research
🇮🇱Beer Sheva, Israel
Technion Sleep Medicine Center, Rambam Medical Center
🇮🇱Haifa, Israel
Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
🇵🇱Gdansk, Poland
Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
🇵🇱Warsaw, Poland
I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
🇸🇰Bratislava, Slovakia
EMC Instytut Medyczny S.A
🇵🇱Wroclaw, Poland
Neurologicka klinika, FN L. Pasteura Kosice
🇸🇰Kosice, Slovakia
BenMed Park Clinic
🇿🇦Benoni, Johannesburg, South Africa
WITS Sleep Laboratory School of Physiology
🇿🇦Parktown, Johannesburg, South Africa
Little Company of Mary Hospital
🇿🇦Pretoria, South Africa
Somerset West Trial Centre
🇿🇦Somerset West, South Africa
Gatesville Medical Centre
🇿🇦Gatesville, Western Cape, South Africa
Hospital Son Dureta, Unidad de Psicologia
🇪🇸Palma de Mallorca, Spain
Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
🇪🇸Barcelona, Spain
Instituto de Investigaciones del Sueno
🇪🇸Madrid, Spain
Hospital La Fe, Unidad de Neurofisiologi
🇪🇸Valencia, Spain
Carlanderska Sömnlaboratoriet
🇸🇪Goteborg, Sweden
Hospital MAZ, Unidad de Neurofisiologia y Sueno
🇪🇸Zaragoza, Spain
Aleris Fysiologlab
🇸🇪Stockholm, Sweden
Örebro University Hospital, Neurology department Sleep Unit
🇸🇪Orebro, Sweden
Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
🇨ðŸ‡Basel, Switzerland
Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
🇨ðŸ‡Chene-Bourg, Switzerland
KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
🇨ðŸ‡Lucerne, Switzerland
National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II
🇺🇦Kiev, Ukraine
University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
🇨ðŸ‡Zurich, Switzerland
KSM Zurzach Klinik fur Schlafmedizin
🇨ðŸ‡Zurzach, Switzerland
The Edinburgh Sleep Centre
🇬🇧Edinburgh, United Kingdom
The London Sleep Centre
🇬🇧London, United Kingdom
IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia
🇮🇹Bologna, Italy
IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno
🇮🇹Milan, Italy
Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa
🇮🇹Pisa, Italy
Scan Sleep ApS, Sovnlaegecentret
🇩🇰Copenhagen, Denmark
Sovnlagecentret - Scan Sleep
🇩🇰Copenhagen, Denmark
Sleep Disorders Laboratory, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Institute for Breathing and Sleep (IBAS)
🇦🇺Heidelburg, Victoria, Australia
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Oddeleni nasledne pece, Nemocnice Ceske Budejovice
🇨🇿Ceske Budejovice, Czech Republic
University of Vienna - Department of Neurology
🇦🇹Vienna, Austria
Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.
🇨🇿Prague, Czech Republic
Department of Neurology , University of Debrecen
ðŸ‡ðŸ‡ºDebrecen, Hungary
Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
🇵🇱Lodz, Poland
Western Hospitpal, Private Bag
🇦🇺Footscray, Victoria, Australia
Hospital St. Naum, Paediatr. Neurology
🇧🇬Sofia, Bulgaria
Centrum pro poruchy spanku a bdeni, Neurologicka klinika
🇨🇿Katerinska, Czech Republic
University of Turku, Sleep Research Unit
🇫🇮Turku, Finland
Laboratorium Diagnostyka Snu, Pro-Medica
🇵🇱Warszawa, Poland
Monash Adult Sleep Center, Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY
🇨🇿Ostava-Poruba, Czech Republic
Dept of Neurology, University of Pecs
ðŸ‡ðŸ‡ºPecs, Hungary