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Eplivanserin

Phase 3

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Sanofi|Last Updated: Mar 1, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment3,054
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00679900Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance DifficultiesPHASE3 COMPLETED 283 — — Apr 1, 2008Mar 1, 2009Nov 30, 20108 Chile, Estonia +6
NCT00308503Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance InsomniaPHASE3 COMPLETED 608 — — Feb 1, 2006Aug 1, 2007Nov 30, 20103 United States, Australia +1
NCT00253903Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 YearPHASE3 COMPLETED 1,155 — — Nov 1, 2005Sep 1, 2008Nov 30, 201014 United States, Argentina +12
NCT00253968Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance InsomniaPHASE3 COMPLETED 967 — — Nov 1, 2005Jan 1, 2008Mar 1, 201612 United States, Argentina +10
NCT00913614Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With InsomniaPHASE1 COMPLETED 41 — — Jun 1, 2009Dec 1, 2009Nov 30, 20101 United States
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Study Endpoints
Primary Endpoints
Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire
4 weeks
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
week 6
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
at week 12
Safety in terms of adverse events, laboratory tests, vital signs, ECGs
Up to 12 days following single dose administration
Pharmacokinetics parameters
on Day 1, Day 2, Day 5, Day 7 and Day 10
Secondary Endpoints
Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)
4 weeks
Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period
4 weeks
Subjective sleep parameters
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
EplivanserinEXPERIMENTALEplivanserin 5 mg/day
PlaceboPLACEBO_COMPARATORPlacebo of Eplivanserin 5 mg /day
Age Group 6-11 year old - Dose level 1EXPERIMENTAL -
Age Group 6-11 year old - Dose Level 2EXPERIMENTAL -
Age Group 6-11 year old - Dose Level 3EXPERIMENTAL -
Age Group 12-17 year old - Dose level 1EXPERIMENTAL -
Age Group 12-17 year old - Dose level 2EXPERIMENTAL -
Age Group 12-17 year old - Dose level 3EXPERIMENTAL -
Interventions
NameTypeDescription
eplivanserin (SR46349)DRUG5 mg/day
lormetazepamDRUG1 mg/day
placeboDRUGoral administration
EplivanserinDRUGoral administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria * At least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion * Disturbances of sleep maintenance criteria based on the patient's sle...

Countries:ChileEstoniaFinlandFranceNetherlandsNorwayPortugalSpainUnited StatesAustraliaCanadaArgentinaAustriaCzechiaGermanyMexicoUnited Kingdom
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