Sleep Initiation and Maintenance DisordersPhase 3GEMSNCT00253968
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
A Phase 3 study testing Eplivanserin in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by Sanofi at 12 sites in 12 countries.
Trial summary
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 967 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Nov 2005to Jan 2008
- 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
- Out patients
- Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
- Based on patient's information, the 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 daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.
Who cannot join
- Females who are lactating or pregnant
- Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
- Patients presenting with acute or chronic pain resulting in insomnia
- Patients with history of epilepsy or seizures
- Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
- Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
Show all 24Show fewer
- BMI >32
- Acute or chronic pain resulting in insomnia
- Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
- Clinically significant and abnormal EKG (QTc interval >=500 msec)
- Positive for hepatitis B or C
- Serious head injury or stroke within 1 year
- Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
- Participation in another trial within two month before the screening visit
- Use of any substance with psychotropic effects or properties known to affect sleep/wake
- Unable to complete the study questionnaires
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- History of:
- Primary hypersomnia
- Narcolepsy
- Breathing-related sleep disorder (such as sleep apnea)
- Circadian rhythm sleep disorder
- Parasomnia (somnambulism)
- Dyssomnia (such as periodic leg movements)
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Read the detailed description
12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)
Total Duration of observation: 15 weeks for each patient
- Being tested
- Eplivanserin, placebo
- Keywords
- Primary Insomnia, Sleeplessness, Early Awakening, Chronic Insomnia
- 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.
EplivanserinDrug
Also called (SR46349)
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Eplivanserin | Experimental | Eplivanserin 5 mg/day Receives: Drug: Eplivanserin |
| Placebo | Placebo comparator | Placebo of Eplivanserin 5 mg /day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Measured: at week 12
Secondary outcomes (2)
Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)
Measured: at week 12
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2008
- Study completionJan 2008
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
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253968
- Sponsor's protocol ID
- LTE6217
- Other IDs
- 2005-003080-23, 2005
- Acronym
- GEMS
- Status last verified
- Feb 2016
- First submitted
- 14 Nov 2005
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. 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 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00253968
- Acronym / sponsor ID
- GEMS / LTE6217
- Keywords
- Primary Insomnia, Sleeplessness, Early Awakening, Chronic Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Nov 2005 (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 purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Detailed description
12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)
Total Duration of observation: 15 weeks for each patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplivanserin | Experimental | Drug: EplivanserinEplivanserin 5 mg/day |
| Placebo | Placebo comparator | Drug: placeboPlacebo of Eplivanserin 5 mg /day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Out patients
- Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
- Based on patient's information, the 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 daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.
Key exclusion criteria (24 listed)
- Females who are lactating or pregnant
- Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
- Patients presenting with acute or chronic pain resulting in insomnia
- Patients with history of epilepsy or seizures
- Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
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 |
|---|---|---|
| EplivanserinAlso: (SR46349)oral administration | Drug | Eplivanserin |
| placebooral administration | Drug | Placebo |
Primary outcome
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Time frame: at week 12
2 secondary outcomes
Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)
Time frame: at week 12
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)
Time frame: at week 12
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 1 Mar 2016.
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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 study director
Sanofi
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplivanserin in people with Sleep Initiation and Maintenance Disorders and Insomnia, run by Sanofi at 12 sites in 12 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 4 inclusion and 24 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Argentina, Australia, Canada, Chile and 7 more countries. 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 the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire) (time frame: at week 12). 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 1 Mar 2016.