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Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (RESTORA 1)

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
almorexant
almorexant
Placebo
zolpidem
Sponsored by
Midnight Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring sleeplessness, orexin receptor antagonist, almorexant, insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sleep Disorders Laboratory, Royal Adelaide Hospital
  • Monash Adult Sleep Center, Monash Medical Centre
  • Western Hospitpal, Private Bag
  • Institute for Breathing and Sleep (IBAS)
  • The Woolcock Institute of Medical Research
  • Australian Clinical Research Organisation
  • Melbourne Sleep Disorder Centre
  • Burnside Hospital Clinical Trials Centre
  • Westmead Hospital, Department of Respiratory
  • Medical University of Innsbruck, Department of Neurology
  • Rudolfinerhaus
  • University of Vienna - Department of Neurology
  • Cliniques Universitaires Saint Luc
  • CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
  • Clinique Andre Vesale
  • Hospital St. Naum, Paediatr. Neurology
  • MHAT 'St. Marina'
  • Oddeleni nasledne pece, Nemocnice Ceske Budejovice
  • Centrum pro poruchy spanku a bdeni, Neurologicka klinika
  • Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY
  • Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.
  • Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie
  • Scansleep Aps, Sovnlaegecentret
  • Sovnlagecentret - Scan Sleep
  • Scan Sleep ApS, Sovnlaegecentret
  • Tutkimuskeskus Vitalmed
  • Unesta Research Center
  • University of Turku, Sleep Research Unit
  • Hopital Pellegrin
  • Hopital Raymond Poincare
  • Service de Neurologie B, Hopital Gui de Chauliac
  • Hopital Pitie-Salpetriere
  • Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
  • Federation des Pathologies du Sommeil
  • Advanced Sleep Research GmbH
  • Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie
  • ClinPharm International GmbH Berlin
  • Klinische Forschung Berlin GmbH
  • St. Hedwig-Krnkenhaus
  • ClinPharm International GmbH Bochum
  • ClinPharm International GmbH Chemnitz
  • ClinPharm International GmbH Dresden
  • ClinPharm International GmbH Frankfurt
  • Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
  • ClinPharm International GmbH Gorlitz
  • Klinische Forschung
  • ClinPharm International GmbH Leipzig
  • ClinPharm International GmbH Magdeburg
  • Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH
  • ClinPharm International GmbH Potsdam
  • Klinik und Poliklinik fur Psychiatre
  • Klinische Forschung Schwerin GmbH
  • SOMNIBENE Institut fur Medizinische
  • Sleep Disorder Centre, State Health Centre
  • Department of Neurology , University of Debrecen
  • Dept of Neurology, University of Pecs
  • Sleep Laboratory, Ilnd Hospital
  • Soroka University Medical Center, Unit for Sleep Research
  • Technion Sleep Medicine Center, Rambam Medical Center
  • IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia
  • IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno
  • Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa
  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
  • Laboratorium Diagnostyka Snu, Pro-Medica
  • Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
  • Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
  • Laboratorium Diagnostyka Snu, Pro-Medica
  • EMC Instytut Medyczny S.A
  • I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
  • Neurologicka klinika, FN L. Pasteura Kosice
  • BenMed Park Clinic
  • WITS Sleep Laboratory School of Physiology
  • Gatesville Medical Centre
  • Little Company of Mary Hospital
  • Somerset West Trial Centre
  • Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
  • Instituto de Investigaciones del Sueno
  • Hospital Son Dureta, Unidad de Psicologia
  • Hospital La Fe, Unidad de Neurofisiologi
  • Hospital MAZ, Unidad de Neurofisiologia y Sueno
  • Carlanderska Sömnlaboratoriet
  • Örebro University Hospital, Neurology department Sleep Unit
  • Aleris Fysiologlab
  • Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
  • Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
  • KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
  • University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
  • KSM Zurzach Klinik fur Schlafmedizin
  • National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II
  • The Edinburgh Sleep Centre
  • The London Sleep Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

almorexant 200 mg

almorexant 100 mg

Placebo

zolpidem 10 mg

Outcomes

Primary Outcome Measures

Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
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&16
Change From Baseline to Day 15&16 in WASO
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&16
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
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

Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
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
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)
sLSO was the self-reported time to fall asleep as reported in the sleep diary

Full Information

First Posted
January 11, 2008
Last Updated
February 11, 2016
Sponsor
Midnight Pharma, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00608985
Brief Title
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Acronym
RESTORA 1
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midnight Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
sleeplessness, orexin receptor antagonist, almorexant, insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
almorexant 200 mg
Arm Title
2
Arm Type
Experimental
Arm Description
almorexant 100 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
4
Arm Type
Active Comparator
Arm Description
zolpidem 10 mg
Intervention Type
Drug
Intervention Name(s)
almorexant
Intervention Description
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
Intervention Type
Drug
Intervention Name(s)
almorexant
Intervention Description
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
Intervention Type
Drug
Intervention Name(s)
zolpidem
Intervention Description
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Primary Outcome Measure Information:
Title
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Description
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&16
Time Frame
From baseline to Day 1&2
Title
Change From Baseline to Day 15&16 in WASO
Description
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&16
Time Frame
From baseline to Day 15&16
Title
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Description
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
Time Frame
From baseline to Week 1&2
Secondary Outcome Measure Information:
Title
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Description
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
Time Frame
From baseline to Day 1&2
Title
Change From Baseline to Day 15&16 in LPS
Description
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
Time Frame
From baseline to Day 15&16
Title
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Description
sLSO was the self-reported time to fall asleep as reported in the sleep diary
Time Frame
From baseline to Week 1&2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Cluydts, Dr.
Organizational Affiliation
Cognitive and Biological Psychology, University of Brussels
Official's Role
Study Chair
Facility Information:
Facility Name
Sleep Disorders Laboratory, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Adult Sleep Center, Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Western Hospitpal, Private Bag
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Institute for Breathing and Sleep (IBAS)
City
Heidelburg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Woolcock Institute of Medical Research
City
Glebe
ZIP/Postal Code
2050
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Kippa Ring
ZIP/Postal Code
4021
Country
Australia
Facility Name
Melbourne Sleep Disorder Centre
City
Melbourne
Country
Australia
Facility Name
Burnside Hospital Clinical Trials Centre
City
Toorak Gardens
ZIP/Postal Code
5065
Country
Australia
Facility Name
Westmead Hospital, Department of Respiratory
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Medical University of Innsbruck, Department of Neurology
City
Innsbruck
Country
Austria
Facility Name
Rudolfinerhaus
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
University of Vienna - Department of Neurology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
City
Haine Saint Paul
Country
Belgium
Facility Name
Clinique Andre Vesale
City
Montigny le Tilleuil
Country
Belgium
Facility Name
Hospital St. Naum, Paediatr. Neurology
City
Sofia
Country
Bulgaria
Facility Name
MHAT 'St. Marina'
City
Varna
Country
Bulgaria
Facility Name
Oddeleni nasledne pece, Nemocnice Ceske Budejovice
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Centrum pro poruchy spanku a bdeni, Neurologicka klinika
City
Katerinska
Country
Czech Republic
Facility Name
Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY
City
Ostava-Poruba
Country
Czech Republic
Facility Name
Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.
City
Prague
Country
Czech Republic
Facility Name
Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie
City
Trutnov
Country
Czech Republic
Facility Name
Scansleep Aps, Sovnlaegecentret
City
Arhus
Country
Denmark
Facility Name
Sovnlagecentret - Scan Sleep
City
Copenhagen
ZIP/Postal Code
1364
Country
Denmark
Facility Name
Scan Sleep ApS, Sovnlaegecentret
City
Copenhagen
Country
Denmark
Facility Name
Tutkimuskeskus Vitalmed
City
Helsinki
Country
Finland
Facility Name
Unesta Research Center
City
Tampere
Country
Finland
Facility Name
University of Turku, Sleep Research Unit
City
Turku
Country
Finland
Facility Name
Hopital Pellegrin
City
Bordeaux
Country
France
Facility Name
Hopital Raymond Poincare
City
Garches
Country
France
Facility Name
Service de Neurologie B, Hopital Gui de Chauliac
City
Montpellier
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
City
Paris
Country
France
Facility Name
Federation des Pathologies du Sommeil
City
Paris
Country
France
Facility Name
Advanced Sleep Research GmbH
City
Berlin
Country
Germany
Facility Name
Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie
City
Berlin
Country
Germany
Facility Name
ClinPharm International GmbH Berlin
City
Berlin
Country
Germany
Facility Name
Klinische Forschung Berlin GmbH
City
Berlin
Country
Germany
Facility Name
St. Hedwig-Krnkenhaus
City
Berlin
Country
Germany
Facility Name
ClinPharm International GmbH Bochum
City
Bochum
Country
Germany
Facility Name
ClinPharm International GmbH Chemnitz
City
Chemnitz
Country
Germany
Facility Name
ClinPharm International GmbH Dresden
City
Dresden
Country
Germany
Facility Name
ClinPharm International GmbH Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg
City
Freiburg
Country
Germany
Facility Name
ClinPharm International GmbH Gorlitz
City
Gorlitz
Country
Germany
Facility Name
Klinische Forschung
City
Hamburg
Country
Germany
Facility Name
ClinPharm International GmbH Leipzig
City
Leipzig
Country
Germany
Facility Name
ClinPharm International GmbH Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH
City
Marburg
Country
Germany
Facility Name
ClinPharm International GmbH Potsdam
City
Potsdam
Country
Germany
Facility Name
Klinik und Poliklinik fur Psychiatre
City
Regensburg
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
Country
Germany
Facility Name
SOMNIBENE Institut fur Medizinische
City
Schwerin
Country
Germany
Facility Name
Sleep Disorder Centre, State Health Centre
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Department of Neurology , University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Dept of Neurology, University of Pecs
City
Pecs
Country
Hungary
Facility Name
Sleep Laboratory, Ilnd Hospital
City
Szeged
ZIP/Postal Code
J-6725
Country
Hungary
Facility Name
Soroka University Medical Center, Unit for Sleep Research
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Technion Sleep Medicine Center, Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia
City
Bologna
ZIP/Postal Code
IT-27100
Country
Italy
Facility Name
IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa
City
Pisa
ZIP/Postal Code
IT-56126
Country
Italy
Facility Name
Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
City
Gdansk
ZIP/Postal Code
890-952
Country
Poland
Facility Name
Laboratorium Diagnostyka Snu, Pro-Medica
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
City
Lodz
ZIP/Postal Code
92-215
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
City
Warsaw
ZIP/Postal Code
02957
Country
Poland
Facility Name
Laboratorium Diagnostyka Snu, Pro-Medica
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
EMC Instytut Medyczny S.A
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Neurologicka klinika, FN L. Pasteura Kosice
City
Kosice
ZIP/Postal Code
04066
Country
Slovakia
Facility Name
BenMed Park Clinic
City
Benoni
State/Province
Johannesburg
Country
South Africa
Facility Name
WITS Sleep Laboratory School of Physiology
City
Parktown
State/Province
Johannesburg
Country
South Africa
Facility Name
Gatesville Medical Centre
City
Gatesville
State/Province
Western Cape
Country
South Africa
Facility Name
Little Company of Mary Hospital
City
Pretoria
Country
South Africa
Facility Name
Somerset West Trial Centre
City
Somerset West
Country
South Africa
Facility Name
Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
City
Barcelona
ZIP/Postal Code
E-08025
Country
Spain
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hospital Son Dureta, Unidad de Psicologia
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital La Fe, Unidad de Neurofisiologi
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital MAZ, Unidad de Neurofisiologia y Sueno
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain
Facility Name
Carlanderska Sömnlaboratoriet
City
Goteborg
ZIP/Postal Code
SE-144 35
Country
Sweden
Facility Name
Örebro University Hospital, Neurology department Sleep Unit
City
Orebro
Country
Sweden
Facility Name
Aleris Fysiologlab
City
Stockholm
Country
Sweden
Facility Name
Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
City
Basel
ZIP/Postal Code
CH-4025
Country
Switzerland
Facility Name
Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
City
Chene-Bourg
ZIP/Postal Code
CH-1225
Country
Switzerland
Facility Name
KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
City
Lucerne
ZIP/Postal Code
CH-6006
Country
Switzerland
Facility Name
University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
KSM Zurzach Klinik fur Schlafmedizin
City
Zurzach
ZIP/Postal Code
CH-5330
Country
Switzerland
Facility Name
National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II
City
Kiev
Country
Ukraine
Facility Name
The Edinburgh Sleep Centre
City
Edinburgh
Country
United Kingdom
Facility Name
The London Sleep Centre
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28735928
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.
Results Reference
derived

Learn more about this trial

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

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