Primary InsomniaPhase 3RESTORA 1NCT00608985

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

A Phase 3 study testing almorexant and zolpidem in people with Primary Insomnia, run by Midnight Pharma, LLC at 91 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Primary Insomnia
What is being tested?: almorexant and zolpidem
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 709 participants
Where: 91 sitesin 20 countries
Study dates: Mar 2008to Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

91 sites in 20 countries.

Country

City, postcode or hospital

91 sites in 20 countries

Germany19 sites

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

Other trials in Germany

Australia9 sites

Sleep Disorders Laboratory, Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Adult Sleep Center, Monash Medical Centre
Clayton, Victoria, 3168
Western Hospitpal, Private Bag
Footscray, Victoria, 3011
The Woolcock Institute of Medical Research
Glebe, 2050
Institute for Breathing and Sleep (IBAS)
Heidelburg, Victoria, 3084
Australian Clinical Research Organisation
Kippa-Ring, 4021
Melbourne Sleep Disorder Centre
Melbourne
Burnside Hospital Clinical Trials Centre
Toorak Gardens, 5065
Westmead Hospital, Department of Respiratory
Westmead, 2145

Other trials in Australia

France6 sites

Hopital Pellegrin
Bordeaux
Hopital Raymond Poincare
Garches
Service de Neurologie B, Hopital Gui de Chauliac
Montpellier
Hopital Pitie-Salpetriere
Paris, 75651
Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris
Paris
Federation des Pathologies du Sommeil
Paris

Other trials in France

Poland6 sites

Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG
Gdansk, 890-952
Laboratorium Diagnostyka Snu, Pro-Medica
Krakow, 30-002
Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu
Lodz, 92-215
Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
Warsaw, 02957
Laboratorium Diagnostyka Snu, Pro-Medica
Warsaw, 04-730
EMC Instytut Medyczny S.A
Wroclaw, 50-220

Other trials in Poland

Czechia5 sites

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

Other trials in Czechia

South Africa5 sites

BenMed Park Clinic
Benoni, Johannesburg
Gatesville Medical Centre
Gatesville, Western Cape
WITS Sleep Laboratory School of Physiology
Parktown, Johannesburg
Little Company of Mary Hospital
Pretoria
Somerset West Trial Centre
Somerset West

Other trials in South Africa

Spain5 sites

Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica
Barcelona, E-08025
Instituto de Investigaciones del Sueno
Madrid, 28036
Hospital Son Dureta, Unidad de Psicologia
Palma de Mallorca, 07014
Hospital La Fe, Unidad de Neurofisiologi
Valencia, 46009
Hospital MAZ, Unidad de Neurofisiologia y Sueno
Zaragoza, 50015

Other trials in Spain

Switzerland5 sites

KSM Zurzach Klinik fur Schlafmedizin
Bad Zurzach, CH-5330
Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology
Basel, CH-4025
Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee
Chêne-Bourg, CH-1225
KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna
Lucerne, CH-6006
University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine
Zurich, CH-8091

Other trials in Switzerland

Hungary4 sites

Sleep Disorder Centre, State Health Centre
Budapest, H-1134
Department of Neurology , University of Debrecen
Debrecen
Dept of Neurology, University of Pecs
Pécs
Sleep Laboratory, Ilnd Hospital
Szeged, J-6725

Other trials in Hungary

Austria3 sites

Medical University of Innsbruck, Department of Neurology
Innsbruck
Rudolfinerhaus
Vienna, A-1090
University of Vienna - Department of Neurology
Vienna, A-1090

Other trials in Austria

Belgium3 sites

Cliniques Universitaires Saint Luc
Brussels
CH Jolimont / Sleep Disorders Center, Hospital de Jolimont
Haine-Saint-Paul
Clinique Andre Vesale
Montigny Le Tilleuil

Other trials in Belgium

Denmark3 sites

Scansleep Aps, Sovnlaegecentret
Aarhus
Sovnlagecentret - Scan Sleep
Copenhagen, 1364
Scan Sleep ApS, Sovnlaegecentret
Copenhagen

Other trials in Denmark

Finland3 sites

Tutkimuskeskus Vitalmed
Helsinki
Unesta Research Center
Tampere
University of Turku, Sleep Research Unit
Turku

Other trials in Finland

Italy3 sites

IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia
Bologna, IT-27100
IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno
Milan, 20127
Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa
Pisa, IT-56126

Other trials in Italy

Sweden3 sites

Carlanderska Sömnlaboratoriet
Gothenburg, SE-144 35
Örebro University Hospital, Neurology department Sleep Unit
Örebro
Aleris Fysiologlab
Stockholm

Other trials in Sweden

Bulgaria2 sites

Hospital St. Naum, Paediatr. Neurology
Sofia
MHAT 'St. Marina'
Varna

Other trials in Bulgaria

Israel2 sites

Soroka University Medical Center, Unit for Sleep Research
Beersheba, 84101
Technion Sleep Medicine Center, Rambam Medical Center
Haifa, 31096

Other trials in Israel

Slovakia2 sites

I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto
Bratislava, 81369
Neurologicka klinika, FN L. Pasteura Kosice
Košice, 04066

Other trials in Slovakia

United Kingdom2 sites

The Edinburgh Sleep Centre
Edinburgh
The London Sleep Centre
London

Other trials in United Kingdom

Ukraine1 site

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

Other trials in Ukraine

About this study

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

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
Being tested: almorexant, Placebo, zolpidem
Keywords: sleeplessness, orexin receptor antagonist, almorexant, insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

almorexantDrug
2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
almorexantDrug
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
PlaceboDrug
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
zolpidemDrug
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Study groups in NCT00608985
Study group	Role	What they receive
1	Experimental	almorexant 200 mg Receives: Drug: almorexant
2	Experimental	almorexant 100 mg Receives: Drug: almorexant
3	Placebo comparator	Placebo Receives: Drug: Placebo
4	Active comparator	zolpidem 10 mg Receives: Drug: zolpidem

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: From baseline to Week 1&2

Secondary outcomes (3)

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
Measured: From baseline to Day 1&2
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
Measured: From baseline to Day 15&16
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
Measured: From baseline to Week 1&2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Nov 2009

First posted6 Feb 2008 (estimated)
Study startMar 2008
Primary completionSep 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 709 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00608985
Sponsor's protocol ID: AC-057A301
Acronym: RESTORA 1
Status last verified: Feb 2016
First submitted: 11 Jan 2008
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28735928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension

All Primary Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00608985
Acronym / sponsor ID: RESTORA 1 / AC-057A301
Conditions: Primary Insomnia
Keywords: sleeplessness, orexin receptor antagonist, almorexant, insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 709 participants (actual)
Lead sponsor: Midnight Pharma, LLCIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Sep 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 6 Feb 2008 (estimated)
Results: Posted 7 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: almorexantalmorexant 200 mg
2	Experimental	Drug: almorexantalmorexant 100 mg
3	Placebo comparator	Drug: PlaceboPlacebo
4	Active comparator	Drug: zolpidemzolpidem 10 mg

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
almorexant2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem	Drug	1
almorexant1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem	Drug	2
Placebo2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem	Drug	3
zolpidem2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated	Drug	4

Primary outcome

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
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
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

3 secondary outcomes

Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Time frame: From baseline to Day 1&2
Change From Baseline to Day 15&16 in LPS
Time frame: 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

Results and safety

Results posted to the registry on 7 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	177	161
Almorexant 100mg	186	173
Almorexant 200mg	176	170
Zolpidem 10mg	168	159

Primary outcome: Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)

Time frame: From baseline to Day 1&2. Median (95% Confidence Interval). Unit: minutes

Measure	Placebo n = 177	Almorexant 100mg n = 186	Almorexant 200mg n = 176	Zolpidem 10mg n = 168
Baseline	85.0 (39.81)	86.6 (39.17)	92.3 (35.92)	76.5 (36.95)
Day 1&2	72.8 (42.63)	54.5 (37.65)	46.4 (28.85)	54.6 (36.05)
Change from baseline to day 1&2	-11.8 (38.73)	-29.0 (31.50)	-40.4 (31.70)	-17.9 (29.19)

Placebo vs Almorexant 100mg: Median Difference (Net): -15.0 (95% CI -21.8 to -8.8), p <0.0001, Wilcoxon rank-sum
Placebo vs Almorexant 200mg: Median Difference (Net): -26.8 (95% CI -34.3 to -19.5), p <0.0001, Wilcoxon rank-sum
Placebo vs Zolpidem 10mg: Median Difference (Net): -6.8 (95% CI -13.5 to -0.3), p = 0.0376, Wilcoxon rank-sum

Population analysed: All treated patients

Primary outcome: Change From Baseline to Day 15&16 in WASO

Time frame: From baseline to Day 15&16. Median (95% Confidence Interval). Unit: minutes

Measure	Placebo n = 177	Almorexant 100mg n = 186	Almorexant 200mg n = 176	Zolpidem 10mg n = 168
Baseline	85.0 (39.81)	86.6 (39.17)	92.3 (35.92)	76.5 (36.95)
Day 15&16	65.0 (45.90)	55.8 (35.07)	51.8 (31.31)	63.0 (42.31)
Change from baseline to Day 15&16	-18.3 (43.40)	-29.6 (33.12)	-36.3 (35.20)	-15.1 (36.61)

Placebo vs Almorexant 100mg: Median Difference (Net): -13.5 (95% CI -20.3 to -6.5), p = 0.0001, Wilcoxon rank-sum
Placebo vs Almorexant 200mg: Median Difference (Net): -19.5 (95% CI -27.3 to -12.3), p <0.0001, Wilcoxon rank-sum
Placebo vs Zolpidem 10mg: Median Difference (Net): 3.5 (95% CI -3.8 to 11.0), p = 0.3358, Wilcoxon rank-sum

Population analysed: All treated patients

Primary outcome: Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)

Time frame: From baseline to Week 1&2. Median (95% Confidence Interval). Unit: minutes

Measure	Placebo n = 175	Almorexant 100mg n = 179	Almorexant 200mg n = 173	Zolpidem 10mg n = 168
Baseline	64.0 (51.32)	65.0 (60.49)	69.0 (46.68)	61.6 (48.29)
Week 1&2	52.9 (48.33)	40.5 (50.87)	42.9 (42.06)	30.5 (42.26)
Change from baseline to week 1&2	-14.1 (31.84)	-19.5 (36.93)	-21.8 (32.5)	-23.4 (33.22)

Placebo vs Almorexant 100mg: Median Difference (Net): -7.3 (95% CI -13.3 to -1.3), p = 0.0186, Wilcoxon rank-sum
Placebo vs Almorexant 200mg: Median Difference (Net): -10.4 (95% CI -16.4 to -4.6), p = 0.0006, Wilcoxon rank-sum
Placebo vs Zolpidem 10mg: Median Difference (Net): -12.7 (95% CI -18.8 to -6.6), p <0.0001, Wilcoxon rank-sum

Population analysed: All treated patients with available data

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 177 (0%)	64 of 177 (36.2%)	Not reported
Almorexant 100mg	2 of 186 (1.1%)	65 of 186 (34.9%)	Not reported
Almorexant 200mg	1 of 176 (0.6%)	61 of 176 (34.7%)	Not reported
Zolpidem 10mg	0 of 168 (0%)	72 of 168 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28735928Black 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.

Related trials for Primary Insomnia

Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond Cluydts, Dr. study chair

Cognitive and Biological Psychology, University of Brussels

91 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing almorexant and zolpidem in people with Primary Insomnia, run by Midnight Pharma, LLC at 91 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Germany, Australia, France, Poland, Czechia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) (time frame: From baseline to Day 1&2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00608985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.