Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

PHASE3CompletedINTERVENTIONAL
Enrollment

709

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

November 30, 2009

Conditions
Primary Insomnia
Interventions
DRUG

almorexant

2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem

DRUG

almorexant

1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

DRUG

Placebo

2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

DRUG

zolpidem

2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Trial Locations (91)

1364

Sovnlagecentret - Scan Sleep, Copenhagen

2050

The Woolcock Institute of Medical Research, Glebe

2145

Westmead Hospital, Department of Respiratory, Westmead

3011

Western Hospitpal, Private Bag, Footscray

3084

Institute for Breathing and Sleep (IBAS), Heidelburg

3168

Monash Adult Sleep Center, Monash Medical Centre, Clayton

4021

Australian Clinical Research Organisation, Kippa-Ring

5000

Sleep Disorders Laboratory, Royal Adelaide Hospital, Adelaide

5065

Burnside Hospital Clinical Trials Centre, Toorak Gardens

20127

IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno, Milan

28036

Instituto de Investigaciones del Sueno, Madrid

31096

Technion Sleep Medicine Center, Rambam Medical Center, Haifa

46009

Hospital La Fe, Unidad de Neurofisiologi, Valencia

50015

Hospital MAZ, Unidad de Neurofisiologia y Sueno, Zaragoza

75651

Hopital Pitie-Salpetriere, Paris

81369

I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto, Bratislava

84101

Soroka University Medical Center, Unit for Sleep Research, Beersheba

Unknown

Melbourne Sleep Disorder Centre, Melbourne

Medical University of Innsbruck, Department of Neurology, Innsbruck

Cliniques Universitaires Saint Luc, Brussels

CH Jolimont / Sleep Disorders Center, Hospital de Jolimont, Haine-Saint-Paul

Clinique Andre Vesale, Montigny Le Tilleuil

Hospital St. Naum, Paediatr. Neurology, Sofia

MHAT 'St. Marina', Varna

Oddeleni nasledne pece, Nemocnice Ceske Budejovice, České Budějovice

Centrum pro poruchy spanku a bdeni, Neurologicka klinika, Katerinska

Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY, Ostava-Poruba

Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o., Prague

Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie, Trutnov

Scansleep Aps, Sovnlaegecentret, Aarhus

Scan Sleep ApS, Sovnlaegecentret, Copenhagen

Tutkimuskeskus Vitalmed, Helsinki

Unesta Research Center, Tampere

University of Turku, Sleep Research Unit, Turku

Hopital Pellegrin, Bordeaux

Hopital Raymond Poincare, Garches

Service de Neurologie B, Hopital Gui de Chauliac, Montpellier

Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris, Paris

Federation des Pathologies du Sommeil, Paris

Advanced Sleep Research GmbH, Berlin

Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie, Berlin

ClinPharm International GmbH Berlin, Berlin

Klinische Forschung Berlin GmbH, Berlin

St. Hedwig-Krnkenhaus, Berlin

ClinPharm International GmbH Bochum, Bochum

ClinPharm International GmbH Chemnitz, Chemnitz

ClinPharm International GmbH Dresden, Dresden

ClinPharm International GmbH Frankfurt, Frankfurt

Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg, Freiburg im Breisgau

ClinPharm International GmbH Gorlitz, Görlitz

Klinische Forschung, Hamburg

ClinPharm International GmbH Leipzig, Leipzig

ClinPharm International GmbH Magdeburg, Magdeburg

Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH, Marburg

ClinPharm International GmbH Potsdam, Potsdam

Klinik und Poliklinik fur Psychiatre, Regensburg

Klinische Forschung Schwerin GmbH, Schwerin

SOMNIBENE Institut fur Medizinische, Schwerin

Department of Neurology , University of Debrecen, Debrecen

Dept of Neurology, University of Pecs, Pécs

BenMed Park Clinic, Benoni

WITS Sleep Laboratory School of Physiology, Parktown

Gatesville Medical Centre, Gatesville

Little Company of Mary Hospital, Pretoria

Somerset West Trial Centre, Somerset West

Örebro University Hospital, Neurology department Sleep Unit, Örebro

Aleris Fysiologlab, Stockholm

National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II, Kiev

The Edinburgh Sleep Centre, Edinburgh

The London Sleep Centre, London

A-1090

Rudolfinerhaus, Vienna

University of Vienna - Department of Neurology, Vienna

H-1134

Sleep Disorder Centre, State Health Centre, Budapest

J-6725

Sleep Laboratory, Ilnd Hospital, Szeged

IT-27100

IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia, Bologna

IT-56126

Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa, Pisa

890-952

Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG, Gdansk

30-002

Laboratorium Diagnostyka Snu, Pro-Medica, Krakow

92-215

Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu, Lodz

02957

Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej, Warsaw

04-730

Laboratorium Diagnostyka Snu, Pro-Medica, Warsaw

50-220

EMC Instytut Medyczny S.A, Wroclaw

04066

Neurologicka klinika, FN L. Pasteura Kosice, Košice

E-08025

Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica, Barcelona

07014

Hospital Son Dureta, Unidad de Psicologia, Palma de Mallorca

SE-144 35

Carlanderska Sömnlaboratoriet, Gothenburg

CH-5330

KSM Zurzach Klinik fur Schlafmedizin, Bad Zurzach

CH-4025

Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology, Basel

CH-1225

Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee, Chêne-Bourg

CH-6006

KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna, Lucerne

CH-8091

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

Sponsors
All Listed Sponsors
lead

Midnight Pharma, LLC

INDUSTRY