Clinical trial NCT00608985: Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: sleeplessness
orexin receptor antagonist
almorexant
insomnia
Lead sponsor: Midnight Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
timeFrame: From baseline to Day 1&2
measure: Change From Baseline to Day 15&16 in WASO
timeFrame: From baseline to Day 15&16
measure: Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
timeFrame: From baseline to Week 1&2
Secondary outcomes:
measure: Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
timeFrame: From baseline to Day 1&2
measure: Change From Baseline to Day 15&16 in LPS
timeFrame: From baseline to Day 15&16
measure: Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
timeFrame: From baseline to Week 1&2
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Sleep Disorders Laboratory, Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Adult Sleep Center, Monash Medical Centre
state: Victoria
city: Footscray
country: Australia
facility: Western Hospitpal, Private Bag
state: Victoria
city: Heidelburg
country: Australia
facility: Institute for Breathing and Sleep (IBAS)
state: Victoria
city: Glebe
country: Australia
facility: The Woolcock Institute of Medical Research
city: Kippa Ring
country: Australia
facility: Australian Clinical Research Organisation
city: Melbourne
country: Australia
facility: Melbourne Sleep Disorder Centre
city: Toorak Gardens
country: Australia
facility: Burnside Hospital Clinical Trials Centre
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Respiratory
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Department of Neurology
city: Vienna
country: Austria
facility: Rudolfinerhaus
city: Vienna
country: Austria
facility: University of Vienna - Department of Neurology
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Haine Saint Paul
country: Belgium
facility: CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
city: Montigny le Tilleuil
country: Belgium
facility: Clinique Andre Vesale
city: Sofia
country: Bulgaria
facility: Hospital St. Naum, Paediatr. Neurology
city: Varna
country: Bulgaria
facility: MHAT 'St. Marina'
city: Ceske Budejovice
country: Czech Republic
facility: Oddeleni nasledne pece, Nemocnice Ceske Budejovice
city: Katerinska
country: Czech Republic
facility: Centrum pro poruchy spanku a bdeni, Neurologicka klinika
city: Ostava-Poruba
country: Czech Republic
facility: Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY
city: Prague
country: Czech Republic
facility: Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.
city: Trutnov
country: Czech Republic
facility: Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie
city: Arhus
country: Denmark
facility: Scansleep Aps, Sovnlaegecentret
city: Copenhagen
country: Denmark
facility: Sovnlagecentret - Scan Sleep
city: Copenhagen
country: Denmark
facility: Scan Sleep ApS, Sovnlaegecentret
city: Helsinki
country: Finland
facility: Tutkimuskeskus Vitalmed
city: Tampere
country: Finland
facility: Unesta Research Center
city: Turku
country: Finland
facility: University of Turku, Sleep Research Unit
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Montpellier
country: France
facility: Service de Neurologie B, Hopital Gui de Chauliac
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
city: Paris
country: France
facility: Federation des Pathologies du Sommeil
city: Berlin
country: Germany
facility: Advanced Sleep Research GmbH
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie
city: Berlin
country: Germany
facility: ClinPharm International GmbH Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin GmbH
city: Berlin
country: Germany
facility: St. Hedwig-Krnkenhaus
city: Bochum
country: Germany
facility: ClinPharm International GmbH Bochum
city: Chemnitz
country: Germany
facility: ClinPharm International GmbH Chemnitz
city: Dresden
country: Germany
facility: ClinPharm International GmbH Dresden
city: Frankfurt
country: Germany
facility: ClinPharm International GmbH Frankfurt
city: Freiburg
country: Germany
facility: Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
city: Gorlitz
country: Germany
facility: ClinPharm International GmbH Gorlitz
city: Hamburg
country: Germany
facility: Klinische Forschung
city: Leipzig
country: Germany
facility: ClinPharm International GmbH Leipzig
city: Magdeburg
country: Germany
facility: ClinPharm International GmbH Magdeburg
city: Marburg
country: Germany
facility: Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH
city: Potsdam
country: Germany
facility: ClinPharm International GmbH Potsdam
city: Regensburg
country: Germany
facility: Klinik und Poliklinik fur Psychiatre
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Schwerin
country: Germany
facility: SOMNIBENE Institut fur Medizinische
city: Budapest
country: Hungary
facility: Sleep Disorder Centre, State Health Centre
city: Debrecen
country: Hungary
facility: Department of Neurology , University of Debrecen
city: Pecs
country: Hungary
facility: Dept of Neurology, University of Pecs
city: Szeged
country: Hungary
facility: Sleep Laboratory, Ilnd Hospital
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center, Unit for Sleep Research
city: Haifa
country: Israel
facility: Technion Sleep Medicine Center, Rambam Medical Center
city: Bologna
country: Italy
facility: IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia
city: Milan
country: Italy
facility: IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno
city: Pisa
country: Italy
facility: Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa
city: Gdansk
country: Poland
facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
city: Krakow
country: Poland
facility: Laboratorium Diagnostyka Snu, Pro-Medica
city: Lodz
country: Poland
facility: Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
city: Warsaw
country: Poland
facility: Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
city: Warszawa
country: Poland
facility: Laboratorium Diagnostyka Snu, Pro-Medica
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A
city: Bratislava
country: Slovakia
facility: I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
city: Kosice
country: Slovakia
facility: Neurologicka klinika, FN L. Pasteura Kosice
city: Benoni
country: South Africa
facility: BenMed Park Clinic
state: Johannesburg
city: Parktown
country: South Africa
facility: WITS Sleep Laboratory School of Physiology
state: Johannesburg
city: Gatesville
country: South Africa
facility: Gatesville Medical Centre
state: Western Cape
city: Pretoria
country: South Africa
facility: Little Company of Mary Hospital
city: Somerset West
country: South Africa
facility: Somerset West Trial Centre
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta, Unidad de Psicologia
city: Valencia
country: Spain
facility: Hospital La Fe, Unidad de Neurofisiologi
city: Zaragoza
country: Spain
facility: Hospital MAZ, Unidad de Neurofisiologia y Sueno
city: Goteborg
country: Sweden
facility: Carlanderska Sömnlaboratoriet
city: Orebro
country: Sweden
facility: Örebro University Hospital, Neurology department Sleep Unit
city: Stockholm
country: Sweden
facility: Aleris Fysiologlab
city: Basel
country: Switzerland
facility: Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
city: Chene-Bourg
country: Switzerland
facility: Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
city: Lucerne
country: Switzerland
facility: KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
city: Zurich
country: Switzerland
facility: University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
city: Zurzach
country: Switzerland
facility: KSM Zurzach Klinik fur Schlafmedizin
city: Kiev
country: Ukraine
facility: National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II
city: Edinburgh
country: United Kingdom
facility: The Edinburgh Sleep Centre
city: London
country: United Kingdom
facility: The London Sleep Centre
Study officials:
affiliation: Cognitive and Biological Psychology, University of Brussels
name: Raymond Cluydts, Dr.
role: STUDY_CHAIR
References:
citation: 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.