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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00608985




Registration number
NCT00608985
Ethics application status
Date submitted
11/01/2008
Date registered
6/02/2008
Date last updated
14/03/2016

Titles & IDs
Public title
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Scientific 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
Secondary ID [1] 0 0
AC-057A301
Universal Trial Number (UTN)
Trial acronym
RESTORA 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - almorexant
Treatment: Drugs - almorexant
Treatment: Drugs - Placebo
Treatment: Drugs - zolpidem

Experimental: 1 - almorexant 200 mg

Experimental: 2 - almorexant 100 mg

Placebo comparator: 3 - Placebo

Active comparator: 4 - zolpidem 10 mg


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

Treatment: Drugs: almorexant
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

Treatment: Drugs: Placebo
2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

Treatment: Drugs: zolpidem
2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Timepoint [1] 0 0
From baseline to Day 1&2
Primary outcome [2] 0 0
Change From Baseline to Day 15&16 in WASO
Timepoint [2] 0 0
From baseline to Day 15&16
Primary outcome [3] 0 0
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Timepoint [3] 0 0
From baseline to Week 1&2
Secondary outcome [1] 0 0
Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Timepoint [1] 0 0
From baseline to Day 1&2
Secondary outcome [2] 0 0
Change From Baseline to Day 15&16 in LPS
Timepoint [2] 0 0
From baseline to Day 15&16
Secondary outcome [3] 0 0
Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Timepoint [3] 0 0
From baseline to Week 1&2

Eligibility
Key inclusion criteria
* Adult subjects (18-64 years) with a diagnosis of primary insomnia.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Sleep Disorders Laboratory, Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Adult Sleep Center, Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Western Hospitpal, Private Bag - Footscray
Recruitment hospital [4] 0 0
Institute for Breathing and Sleep (IBAS) - Heidelburg
Recruitment hospital [5] 0 0
The Woolcock Institute of Medical Research - Glebe
Recruitment hospital [6] 0 0
Australian Clinical Research Organisation - Kippa Ring
Recruitment hospital [7] 0 0
Melbourne Sleep Disorder Centre - Melbourne
Recruitment hospital [8] 0 0
Burnside Hospital Clinical Trials Centre - Toorak Gardens
Recruitment hospital [9] 0 0
Westmead Hospital, Department of Respiratory - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3084 - Heidelburg
Recruitment postcode(s) [5] 0 0
2050 - Glebe
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Haine Saint Paul
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Belgium
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Montigny le Tilleuil
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Czech Republic
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Ceske Budejovice
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Czech Republic
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Katerinska
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Czech Republic
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Ostava-Poruba
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Czech Republic
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Prague
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Czech Republic
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Trutnov
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Denmark
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Arhus
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Denmark
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Copenhagen
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Finland
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Helsinki
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Finland
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Tampere
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Finland
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Turku
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France
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Bordeaux
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France
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Garches
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Paris
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Berlin
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Bochum
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Chemnitz
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Frankfurt
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Freiburg
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Gorlitz
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Hamburg
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Leipzig
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Magdeburg
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Marburg
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Potsdam
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Germany
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Regensburg
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Germany
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Schwerin
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Hungary
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Szeged
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Israel
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Beer Sheva
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Israel
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Haifa
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Italy
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Bologna
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Italy
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Milan
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Italy
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Pisa
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Poland
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Gdansk
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Krakow
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Lodz
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Warsaw
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Warszawa
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Wroclaw
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Johannesburg
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South Africa
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Western Cape
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South Africa
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Pretoria
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South Africa
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Somerset West
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Barcelona
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Madrid
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Palma de Mallorca
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Goteborg
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Sweden
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Orebro
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Stockholm
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Switzerland
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Basel
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Switzerland
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Chene-Bourg
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Switzerland
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Lucerne
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Switzerland
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Zurich
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Switzerland
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Zurzach
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Ukraine
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Kiev
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United Kingdom
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Edinburgh
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Midnight Pharma, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00608985
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Raymond Cluydts, Dr.
Address 0 0
Cognitive and Biological Psychology, University of Brussels
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00608985