Sleep Initiation and Maintenance DisordersPhase 3NOCTURNE907NCT00464243
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
A Phase 3 study testing volinanserin in people with Sleep Initiation and Maintenance Disorders, run by Sanofi at 7 sites in 7 countries.
Trial summary
The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative 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
- What is being tested?
- volinanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Apr 2007to 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
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
- Specific criteria based on the NPSG recordings during the screening nights
Who cannot join
- Females who are lactating or who are pregnant
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
- Participation in another trial having received study medication within 1 month before the screening visit
- Body Mass Index ≥ 33
- Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
Show all 11Show fewer
- Use of any substance with psychotropic effects or properties know to affect sleep/wake
- History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
- Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
- Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study
The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
- Being tested
- volinanserin, placebo
- Keywords
- Sleep problems, Insomnia, Sleeplessness, Polysomnographic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volinanserinDrug
Also called M100907
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Volinanserin | Experimental | 2 mg volinanserin tablets orally once daily Receives: Drug: volinanserin |
| Placebo | Placebo comparator | tablets orally once daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).
Measured: 6 weeks
Secondary outcomes (1)
Functional Outcomes of Sleep Questionnaire at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startApr 2007
- 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
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464243
- Sponsor's protocol ID
- EFC6072
- Other IDs
- EUDRACT : 2006-005303-34
- Acronym
- NOCTURNE907
- Status last verified
- Aug 2017
- First submitted
- 20 Apr 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study
- ClinicalTrials.gov ID
- NCT00464243
- Acronym / sponsor ID
- NOCTURNE907 / EFC6072
- Keywords
- Sleep problems, Insomnia, Sleeplessness, Polysomnographic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Apr 2007 (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 this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volinanserin | Experimental | Drug: volinanserin2 mg volinanserin tablets orally once daily |
| Placebo | Placebo comparator | Drug: placebotablets orally once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
- Specific criteria based on the NPSG recordings during the screening nights
Key exclusion criteria (11 listed)
- Females who are lactating or who are pregnant
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
- Participation in another trial having received study medication within 1 month before the screening visit
- Body Mass Index ≥ 33
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 |
|---|---|---|
| volinanserinAlso: M100907oral administration | Drug | Volinanserin |
| placebooral administration | Drug | Placebo |
Primary outcome
Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).
Time frame: 6 weeks
1 secondary outcome
Functional Outcomes of Sleep Questionnaire at 6 weeks
Time frame: 6 weeks
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 8 Aug 2017.
- Related InfoLink provided by the sponsor.
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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
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing volinanserin in people with Sleep Initiation and Maintenance Disorders, run by Sanofi at 7 sites in 7 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 3 inclusion and 11 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Austria, Canada, France and 2 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 to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO). (time frame: 6 weeks). 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 8 Aug 2017.