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

Primary Insomnia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608985
• Other study ID #: AC-057A301
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2008
• Last updated: February 11, 2016
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: Midnight Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthSwitzerland: SwissmedicCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencySouth Africa: Medicines Control CouncilHungary: National Institute of PharmacyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Australia: Department of Health and Ageing Therapeutic Goods AdministrationIsrael: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsItaly: The Italian Medicines AgencySweden: Medical Products AgencyBulgaria: Bulgarian Drug AgencySpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• almorexant
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
• almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
• Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
• zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Midnight Pharma, LLC

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	From baseline to Day 1&2	No
Secondary	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	From baseline to Day 15&16	No
Secondary	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	From baseline to Week 1&2	No