|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00608985 |
|
Date of registration:
|
11/01/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
RESTORA 1 |
|
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 |
|
Date of first enrolment:
|
March 2008 |
|
Target sample size:
|
709 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00608985 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
|
Austria
|
Belgium
|
Bulgaria
|
Czech Republic
|
Denmark
|
Finland
|
France
|
|
Germany
|
Hungary
|
Israel
|
Italy
|
Poland
|
Slovakia
|
South Africa
|
Spain
|
|
Sweden
|
Switzerland
|
Ukraine
|
United Kingdom
| | | | |
|
Contacts
|
|
Name:
|
Raymond Cluydts, Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cognitive and Biological Psychology, University of Brussels |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Primary Insomnia
|
|
Intervention(s)
|
|
Drug: almorexant
|
|
Drug: zolpidem
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
[Time Frame: From baseline to Week 1&2]
|
|
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
[Time Frame: From baseline to Day 1&2]
|
|
Change From Baseline to Day 15&16 in WASO
[Time Frame: From baseline to Day 15&16]
|
|
Secondary Outcome(s)
|
|
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 Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
[Time Frame: From baseline to Week 1&2]
|
|
Change From Baseline to Day 15&16 in LPS
[Time Frame: From baseline to Day 15&16]
|
|
Secondary ID(s)
|
|
AC-057A301
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|