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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study
Secondary ID [1] 0 0
EFC6220
Universal Trial Number (UTN)
Trial acronym
EPOCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Initiation and Maintenance Disorders 0 0
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 - eplivanserin (SR46349)
Treatment: Drugs - placebo

Experimental: 1 - 5 mg/day

Placebo comparator: 2 -


Treatment: Drugs: eplivanserin (SR46349)
oral administration

Treatment: Drugs: placebo
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
Timepoint [1] 0 0
week 6
Secondary outcome [1] 0 0
Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)
Timepoint [1] 0 0
week 6
Secondary outcome [2] 0 0
Change from baseline in patient reported wake after sleep onset (pr-WASO)
Timepoint [2] 0 0
week 6

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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 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
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Laval

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00308503
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
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/NCT00308503