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

NCT00608985 | Completed Phase 3 Results

• 1 other identifier: AC-057A301
• Study Type: interventional
• Target: 709
• Locations: 19 countries
• Sites: 82

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.

Conditions

Primary Insomnia

Keywords

sleeplessness; orexin receptor antagonist; almorexant; insomnia

Outcome Measures

Primary Outcomes (3)

• 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

  From baseline to Day 1&2

• 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

  From baseline to 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

  From baseline to Week 1&2

Secondary Outcomes (3)

• Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)

  From baseline to Day 1&2

• Change From Baseline to Day 15&16 in LPS

  From baseline to Day 15&16

• Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)

  From baseline to Week 1&2

Study Arms (4)

1

EXPERIMENTAL

almorexant 200 mg

Drug: almorexant

2

EXPERIMENTAL

almorexant 100 mg

Drug: almorexant

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

4

ACTIVE COMPARATOR

zolpidem 10 mg

Drug: zolpidem

Interventions

almorexant DRUG

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

1

Placebo DRUG

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

3

zolpidem DRUG

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

4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midnight Pharma, LLC: lead

Study Sites (91)

Sleep Disorders Laboratory, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Adult Sleep Center, Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Western Hospitpal, Private Bag

Footscray, Victoria, 3011, Australia

Location

Institute for Breathing and Sleep (IBAS)

Heidelburg, Victoria, 3084, Australia

Location

The Woolcock Institute of Medical Research

Glebe, 2050, Australia

Location

Australian Clinical Research Organisation

Kippa-Ring, 4021, Australia

Location

Melbourne Sleep Disorder Centre

Melbourne, Australia

Location

Burnside Hospital Clinical Trials Centre

Toorak Gardens, 5065, Australia

Location

Westmead Hospital, Department of Respiratory

Westmead, 2145, Australia

Location

Medical University of Innsbruck, Department of Neurology

Innsbruck, Austria

Location

Rudolfinerhaus

Vienna, A-1090, Austria

Location

University of Vienna - Department of Neurology

Vienna, A-1090, Austria

Location

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

CH Jolimont / Sleep Disorders Center, Hospital de Jolimont

Haine-Saint-Paul, Belgium

Location

Clinique Andre Vesale

Montigny Le Tilleuil, Belgium

Location

Hospital St. Naum, Paediatr. Neurology

Sofia, Bulgaria

Location

MHAT 'St. Marina'

Varna, Bulgaria

Location

Oddeleni nasledne pece, Nemocnice Ceske Budejovice

České Budějovice, Czechia

Location

Centrum pro poruchy spanku a bdeni, Neurologicka klinika

Katerinska, Czechia

Location

Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY

Ostava-Poruba, Czechia

Location

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

Prague, Czechia

Location

Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie

Trutnov, Czechia

Location

Scansleep Aps, Sovnlaegecentret

Aarhus, Denmark

Location

Sovnlagecentret - Scan Sleep

Copenhagen, 1364, Denmark

Location

Scan Sleep ApS, Sovnlaegecentret

Copenhagen, Denmark

Location

Tutkimuskeskus Vitalmed

Helsinki, Finland

Location

Unesta Research Center

Tampere, Finland

Location

University of Turku, Sleep Research Unit

Turku, Finland

Location

Hopital Pellegrin

Bordeaux, France

Location

Hopital Raymond Poincare

Garches, France

Location

Service de Neurologie B, Hopital Gui de Chauliac

Montpellier, France

Location

Hopital Pitie-Salpetriere

Paris, 75651, France

Location

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

Paris, France

Location

Federation des Pathologies du Sommeil

Paris, France

Location

Advanced Sleep Research GmbH

Berlin, Germany

Location

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

Berlin, Germany

Location

ClinPharm International GmbH Berlin

Berlin, Germany

Location

Klinische Forschung Berlin GmbH

Berlin, Germany

Location

St. Hedwig-Krnkenhaus

Berlin, Germany

Location

ClinPharm International GmbH Bochum

Bochum, Germany

Location

ClinPharm International GmbH Chemnitz

Chemnitz, Germany

Location

ClinPharm International GmbH Dresden

Dresden, Germany

Location

ClinPharm International GmbH Frankfurt

Frankfurt, Germany

Location

Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

Freiburg im Breisgau, Germany

Location

ClinPharm International GmbH Gorlitz

Görlitz, Germany

Location

Klinische Forschung

Hamburg, Germany

Location

ClinPharm International GmbH Leipzig

Leipzig, Germany

Location

ClinPharm International GmbH Magdeburg

Magdeburg, Germany

Location

Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH

Marburg, Germany

Location

ClinPharm International GmbH Potsdam

Potsdam, Germany

Location

Klinik und Poliklinik fur Psychiatre

Regensburg, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Germany

Location

SOMNIBENE Institut fur Medizinische

Schwerin, Germany

Location

Sleep Disorder Centre, State Health Centre

Budapest, H-1134, Hungary

Location

Department of Neurology , University of Debrecen

Debrecen, Hungary

Location

Dept of Neurology, University of Pecs

Pécs, Hungary

Location

Sleep Laboratory, Ilnd Hospital

Szeged, J-6725, Hungary

Location

Soroka University Medical Center, Unit for Sleep Research

Beersheba, 84101, Israel

Location

Technion Sleep Medicine Center, Rambam Medical Center

Haifa, 31096, Israel

Location

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

Bologna, IT-27100, Italy

Location

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

Milan, 20127, Italy

Location

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

Pisa, IT-56126, Italy

Location

Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG

Gdansk, 890-952, Poland

Location

Laboratorium Diagnostyka Snu, Pro-Medica

Krakow, 30-002, Poland

Location

Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu

Lodz, 92-215, Poland

Location

Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

Warsaw, 02957, Poland

Location

Laboratorium Diagnostyka Snu, Pro-Medica

Warsaw, 04-730, Poland

Location

EMC Instytut Medyczny S.A

Wroclaw, 50-220, Poland

Location

I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto

Bratislava, 81369, Slovakia

Location

Neurologicka klinika, FN L. Pasteura Kosice

Košice, 04066, Slovakia

Location

BenMed Park Clinic

Benoni, Johannesburg, South Africa

Location

WITS Sleep Laboratory School of Physiology

Parktown, Johannesburg, South Africa

Location

Gatesville Medical Centre

Gatesville, Western Cape, South Africa

Location

Little Company of Mary Hospital

Pretoria, South Africa

Location

Somerset West Trial Centre

Somerset West, South Africa

Location

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

Barcelona, E-08025, Spain

Location

Instituto de Investigaciones del Sueno

Madrid, 28036, Spain

Location

Hospital Son Dureta, Unidad de Psicologia

Palma de Mallorca, 07014, Spain

Location

Hospital La Fe, Unidad de Neurofisiologi

Valencia, 46009, Spain

Location

Hospital MAZ, Unidad de Neurofisiologia y Sueno

Zaragoza, 50015, Spain

Location

Carlanderska Sömnlaboratoriet

Gothenburg, SE-144 35, Sweden

Location

Örebro University Hospital, Neurology department Sleep Unit

Örebro, Sweden

Location

Aleris Fysiologlab

Stockholm, Sweden

Location

KSM Zurzach Klinik fur Schlafmedizin

Bad Zurzach, CH-5330, Switzerland

Location

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

Basel, CH-4025, Switzerland

Location

Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee

Chêne-Bourg, CH-1225, Switzerland

Location

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

Lucerne, CH-6006, Switzerland

Location

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

Zurich, CH-8091, Switzerland

Location

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

Location

The Edinburgh Sleep Centre

Edinburgh, United Kingdom

Location

The London Sleep Centre

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28735928 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

almorexant; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ouali Berkani/Clinical Trial Leader
• Organization: Actelion Pharmaceuticals Ltd

+41 61 565 5342

Study Officials

• Raymond Cluydts, Dr.

  Cognitive and Biological Psychology, University of Brussels

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 14, 2016
• Results First Posted: February 7, 2013

Record last verified: 2016-02

Locations

IL (2); SE (3); FI (3); CH (5); CZ (5); AU (3); ZA (5); PL (6); FR (6); BU (2); HU (4); SL (2); DK (3); IT (3); UA (1); ES (5); GB (2); DE (19); BE (3)