Recent Updates
Recently added Catalysts

volinanserin

Phase 3

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Sanofi|Last Updated: Aug 8, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,452
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00495885Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes MellitusPHASE3 COMPLETED 848 — — Jun 1, 2007Oct 1, 2008May 26, 201616 United States, Brazil +14
NCT00464243Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic StudyPHASE3 COMPLETED 604 — — Apr 1, 2007Jan 1, 2008Aug 8, 20177 United States, Australia +5
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
12 weeks
Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).
6 weeks
Secondary Endpoints
Change from baseline to 12-week of "General Productivity" domain from Functional Outcomes of Sleep Questionnaire (FOSQ).
12 weeks
Functional Outcomes of Sleep Questionnaire at 6 weeks
6 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VolinanserinEXPERIMENTALVolinanserin 2 mg for a maximum of 87 days
PlaceboPLACEBO_COMPARATORPlacebo for volinanserin for a maximum of 106 days
Interventions
NameTypeDescription
volinanserin (M100907)DRUGoral, one tablet taken around bedtime
PlaceboDRUGoral, one tablet taken around bedtime
volinanserinDRUGoral administration
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * 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 Sub-study : * Patients will ...

Countries:United StatesBrazilCanadaColombiaCzechiaFinlandFranceGreeceItalyMalaysiaNetherlandsRussiaSouth AfricaSwitzerlandTaiwanTurkey (Türkiye)AustraliaAustriaGermany
Unlock Eligibility Criteria