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

February 11, 2016 updated by: Midnight Pharma, LLC

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

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

709

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Placebo
Drug: Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
EXPERIMENTAL: 1
almorexant 200 mg
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
EXPERIMENTAL: 2
almorexant 100 mg
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
ACTIVE_COMPARATOR: 4
zolpidem 10 mg
Drug: zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Time Frame: 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&16
From baseline to Day 1&2
Change From Baseline to Day 15&16 in WASO
Time Frame: 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&16
From baseline to Day 15&16
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Time Frame: 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
From baseline to Week 1&2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Time Frame: 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
From baseline to Day 1&2
Change From Baseline to Day 15&16 in LPS
Time Frame: 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
From baseline to Day 15&16
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Time Frame: From baseline to Week 1&2
sLSO was the self-reported time to fall asleep as reported in the sleep diary
From baseline to Week 1&2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midnight Pharma, LLC

Investigators

  • Study Chair: Raymond Cluydts, Dr., Cognitive and Biological Psychology, University of Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-057A301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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