Sleep Initiation and Maintenance DisordersPhase 3EPOCHNCT00308503
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
A Phase 3 study testing eplivanserin (SR46349) in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by Sanofi at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Insomnia
- What is being tested?
- eplivanserin (SR46349)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 608 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2006to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study
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.
- Being tested
- eplivanserin (SR46349), placebo
- Keywords
- Primary Insomnia, Sleep Maintenance Insomnia, Awakening
- 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.
eplivanserin (SR46349)Drug
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5 mg/day Receives: Drug: eplivanserin (SR46349) |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
Measured: week 6
Secondary outcomes (2)
Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)
Measured: week 6
Change from baseline in patient reported wake after sleep onset (pr-WASO)
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308503
- Sponsor's protocol ID
- EFC6220
- Acronym
- EPOCH
- Status last verified
- Nov 2010
- First submitted
- 28 Mar 2006
- Last updated
- 30 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00308503
- Acronym / sponsor ID
- EPOCH / EFC6220
- Keywords
- Primary Insomnia, Sleep Maintenance Insomnia, Awakening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eplivanserin (SR46349)5 mg/day |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights.
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| eplivanserin (SR46349)oral administration | Drug | 1 |
| placebooral administration | Drug | 2 |
Primary outcome
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
Time frame: week 6
2 secondary outcomes
Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)
Time frame: week 6
Change from baseline in patient reported wake after sleep onset (pr-WASO)
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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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.
ICD CSD study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eplivanserin (SR46349) in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by Sanofi at 3 sites in 3 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 7 inclusion and 17 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 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of night polysomnography Wake Time After Sleep Onset (PSG WASO) (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2010.