Sleep Initiation and Maintenance DisordersPhase 3SAMSNCT00464061
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
A Phase 3 study testing Volinanserin in people with Sleep Initiation and Maintenance Disorders, run by Sanofi at 22 sites in 22 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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus. 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
- 1,847 participants
- Where
- 22 sitesin 22 countries
- Study dates
- Apr 2007to Mar 2009
- 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 participant's information related to sleep pattern during the preceding month
- Sub-study :
- Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)
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 participant's potential participation in a clinical trial.
Trial locations and contacts
22 sites in 22 countries.
22 sites in 22 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford, Surrey
About this study
Official title: Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled 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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
- Being tested
- Volinanserin, Placebo
- Keywords
- Sleep problems, Insomnia, Sleeplessness, Primary insomnia, Insomnia disorder
- 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 | Not described Receives: Drug: Volinanserin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
Measured: at 3 months
Efficacy (sub-study): change from baseline for glycemic measure HbA1c
Measured: at 6 and 12 months
Secondary outcomes (3)
Efficacy: change from baseline of the pr-WASO
Measured: at 6 and 12 months
Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
Measured: at 3 months
Safety: adverse events and laboratory abnormalities
Measured: during 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems
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
- 1,847 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
- NCT00464061
- Sponsor's protocol ID
- LTE6673
- Other IDs
- EudraCT : 2006-004942-18
- Acronym
- SAMS
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2007
- Last updated
- 26 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00464061
- Acronym / sponsor ID
- SAMS / LTE6673
- Keywords
- Sleep problems, Insomnia, Sleeplessness, Primary insomnia, Insomnia disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems
- Enrolment
- 1,847 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
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: Volinanserin |
| Placebo | 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 (4 listed)
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- Disturbances of sleep maintenance criteria based on participant's information related to sleep pattern during the preceding month
- Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)
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
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
Time frame: at 3 months
Efficacy (sub-study): change from baseline for glycemic measure HbA1c
Time frame: at 6 and 12 months
3 secondary outcomes
Efficacy: change from baseline of the pr-WASO
Time frame: at 6 and 12 months
Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
Time frame: at 3 months
Safety: adverse events and laboratory abnormalities
Time frame: during 12 months of treatment
Results and safety
The study was stopped early (reason given: Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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 CSD study director
Sanofi
22 sites in 22 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 22 sites in 22 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 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: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Argentina, Australia, Austria, Belgium and 17 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 was stopped early (reason given: Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems). Results are not available in the source record.
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?
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) (time frame: at 3 months). The study lists 2 primary outcomes in all. 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 26 May 2016.