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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00308503
Registration number
NCT00308503
Ethics application status
Date submitted
28/03/2006
Date registered
29/03/2006
Date last updated
30/11/2010
Titles & IDs
Public title
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
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Scientific title
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study
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Secondary ID [1]
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EFC6220
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Universal Trial Number (UTN)
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Trial acronym
EPOCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep Initiation and Maintenance Disorders
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Insomnia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - eplivanserin (SR46349)
Treatment: Drugs - placebo
Experimental: 1 - 5 mg/day
Placebo Comparator: 2 -
Treatment: Drugs: eplivanserin (SR46349)
oral administration
Treatment: Drugs: placebo
oral administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
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Assessment method [1]
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Timepoint [1]
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week 6
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Secondary outcome [1]
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Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)
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Assessment method [1]
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Timepoint [1]
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week 6
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Secondary outcome [2]
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Change from baseline in patient reported wake after sleep onset (pr-WASO)
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Assessment method [2]
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Timepoint [2]
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week 6
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Eligibility
Key inclusion criteria
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month
preceding the study visit.
- Disturbance of sleep maintenance:
- Based on patient' s information:
- Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed,
each night, over the preceding two weeks,
- Patient must complain of at least one hour of wakefulness after sleep onset
for at least 3 nights per week over the preceding month,
- Patient must report impact on daytime functioning associated with sleep
maintenance insomnia
Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the
sleep laboratory during the two screening nights.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Females who are lactating or who are pregnant, or of childbearing potential not using
an acceptable form of contraception
- Patients presenting with acute or chronic pain resulting in insomnia
- Patients with current psychiatric disturbances
- Body mass index > 32
- Evidence of any clinically significant, severe or unstable, acute or chronically
progressive medical or surgical disorder, or any condition that may interfere with the
absorption, metabolism, distribution or excretion of the study drug, or may affect
patient safety
- Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms),
- A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C
virus [HCV] antibodies)
- Positive qualitative urine drug screen at screening
- Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising
usually more than 5 cups or glasses per day
- Use of any over-the-counter or prescription sleep medication, or of any substance with
psychotropic effects or properties known to affect sleep/wake, within one week or five
half-lives (whichever is longer), prior to screening
- Night shift workers, and individuals who nap 3 or more times per week over the
preceding month
- Based on medical history and/or NPSG:
- primary hypersomnia
- narcolepsy
- breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep)
- circadian rhythm sleep disorder
- parasomnia (e.g. somnambulism)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2007
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Sample size
Target
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Accrual to date
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Final
608
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sanofi-Aventis - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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Canada
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State/province [2]
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Laval
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance
of patients with primary insomnia using night polysomnography recordings over a 6-week
treatment period corresponding to a stabilization of improvement of sleep.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00308503
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00308503
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