Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
NCT ID: NCT00608985
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2008-03-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
almorexant 200 mg
almorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
2
almorexant 100 mg
almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
3
Placebo
Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
4
zolpidem 10 mg
zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Interventions
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almorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Midnight Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Raymond Cluydts, Dr.
Role: STUDY_CHAIR
Cognitive and Biological Psychology, University of Brussels
Locations
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Sleep Disorders Laboratory, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Adult Sleep Center, Monash Medical Centre
Clayton, Victoria, Australia
Western Hospitpal, Private Bag
Footscray, Victoria, Australia
Institute for Breathing and Sleep (IBAS)
Heidelburg, Victoria, Australia
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
Westmead Hospital, Department of Respiratory
Westmead, , Australia
Medical University of Innsbruck, Department of Neurology
Innsbruck, , Austria
Rudolfinerhaus
Vienna, , Austria
University of Vienna - Department of Neurology
Vienna, , Austria
Cliniques Universitaires Saint Luc
Brussels, , Belgium
CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
Haine-Saint-Paul, , Belgium
Clinique Andre Vesale
Montigny Le Tilleuil, , Belgium
Hospital St. Naum, Paediatr. Neurology
Sofia, , Bulgaria
MHAT 'St. Marina'
Varna, , Bulgaria
Oddeleni nasledne pece, Nemocnice Ceske Budejovice
České Budějovice, , Czechia
Centrum pro poruchy spanku a bdeni, Neurologicka klinika
Katerinska, , Czechia
Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY
Ostava-Poruba, , Czechia
Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.
Prague, , Czechia
Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie
Trutnov, , Czechia
Scansleep Aps, Sovnlaegecentret
Aarhus, , Denmark
Sovnlagecentret - Scan Sleep
Copenhagen, , Denmark
Scan Sleep ApS, Sovnlaegecentret
Copenhagen, , Denmark
Tutkimuskeskus Vitalmed
Helsinki, , Finland
Unesta Research Center
Tampere, , Finland
University of Turku, Sleep Research Unit
Turku, , Finland
Hopital Pellegrin
Bordeaux, , France
Hopital Raymond Poincare
Garches, , France
Service de Neurologie B, Hopital Gui de Chauliac
Montpellier, , France
Hopital Pitie-Salpetriere
Paris, , France
Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
Paris, , France
Federation des Pathologies du Sommeil
Paris, , France
Advanced Sleep Research GmbH
Berlin, , Germany
Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie
Berlin, , Germany
ClinPharm International GmbH Berlin
Berlin, , Germany
Klinische Forschung Berlin GmbH
Berlin, , Germany
St. Hedwig-Krnkenhaus
Berlin, , Germany
ClinPharm International GmbH Bochum
Bochum, , Germany
ClinPharm International GmbH Chemnitz
Chemnitz, , Germany
ClinPharm International GmbH Dresden
Dresden, , Germany
ClinPharm International GmbH Frankfurt
Frankfurt, , Germany
Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
Freiburg im Breisgau, , Germany
ClinPharm International GmbH Gorlitz
Görlitz, , Germany
Klinische Forschung
Hamburg, , Germany
ClinPharm International GmbH Leipzig
Leipzig, , Germany
ClinPharm International GmbH Magdeburg
Magdeburg, , Germany
Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH
Marburg, , Germany
ClinPharm International GmbH Potsdam
Potsdam, , Germany
Klinik und Poliklinik fur Psychiatre
Regensburg, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
SOMNIBENE Institut fur Medizinische
Schwerin, , Germany
Sleep Disorder Centre, State Health Centre
Budapest, , Hungary
Department of Neurology , University of Debrecen
Debrecen, , Hungary
Dept of Neurology, University of Pecs
Pécs, , Hungary
Sleep Laboratory, Ilnd Hospital
Szeged, , Hungary
Soroka University Medical Center, Unit for Sleep Research
Beersheba, , Israel
Technion Sleep Medicine Center, Rambam Medical Center
Haifa, , Israel
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
Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
Gdansk, , Poland
Laboratorium Diagnostyka Snu, Pro-Medica
Krakow, , Poland
Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
Lodz, , Poland
Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
Warsaw, , Poland
Laboratorium Diagnostyka Snu, Pro-Medica
Warsaw, , Poland
EMC Instytut Medyczny S.A
Wroclaw, , Poland
I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
Bratislava, , Slovakia
Neurologicka klinika, FN L. Pasteura Kosice
Košice, , Slovakia
BenMed Park Clinic
Benoni, Johannesburg, South Africa
WITS Sleep Laboratory School of Physiology
Parktown, Johannesburg, South Africa
Gatesville Medical Centre
Gatesville, Western Cape, South Africa
Little Company of Mary Hospital
Pretoria, , South Africa
Somerset West Trial Centre
Somerset West, , South Africa
Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
Barcelona, , Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
Hospital Son Dureta, Unidad de Psicologia
Palma de Mallorca, , Spain
Hospital La Fe, Unidad de Neurofisiologi
Valencia, , Spain
Hospital MAZ, Unidad de Neurofisiologia y Sueno
Zaragoza, , Spain
Carlanderska Sömnlaboratoriet
Gothenburg, , Sweden
Örebro University Hospital, Neurology department Sleep Unit
Örebro, , Sweden
Aleris Fysiologlab
Stockholm, , Sweden
KSM Zurzach Klinik fur Schlafmedizin
Bad Zurzach, , Switzerland
Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
Basel, , Switzerland
Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
Chêne-Bourg, , Switzerland
KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
Lucerne, , Switzerland
University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
Zurich, , 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
The Edinburgh Sleep Centre
Edinburgh, , United Kingdom
The London Sleep Centre
London, , United Kingdom
Countries
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References
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Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.
Other Identifiers
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AC-057A301
Identifier Type: -
Identifier Source: org_study_id
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