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Eplivanserin

Phase 3

Primary Insomnia | Small molecule | Psychiatry |Sanofi|Last Updated: Mar 7, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment637

FDA Designations

No designations recorded

Clinical trial landscape

Eplivanserin · 7 trials · 6 indications

Phase 3 5Phase 2 1Phase 1 1
NCT00805350Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance DifficultiesPrimary Insomnia
COMPLETED637 Analytics
NCT00679900Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance DifficultiesSleep Initiation and Maintenance Disorders
COMPLETED283 Analytics
NCT00308503Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance InsomniaSleep Initiation and Maintenance Disorders
COMPLETED608 Analytics
NCT00253903Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 YearSleep Initiation and Maintenance Disorders
COMPLETED1,155 Analytics
NCT00253968Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance InsomniaSleep Initiation and Maintenance Disorders
COMPLETED967 Analytics
PHASE3COMPLETED
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
Primary Insomnia
NCT00805350637
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PHASE3COMPLETED
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Sleep Initiation and Maintenance Disorders
NCT00679900283
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PHASE3COMPLETED
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
Sleep Initiation and Maintenance Disorders
NCT00308503608
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PHASE3COMPLETED
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year
Sleep Initiation and Maintenance Disorders
NCT002539031,155
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PHASE3COMPLETED
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Sleep Initiation and Maintenance Disorders
NCT00253968967
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Study Endpoints

Primary Endpoints

Change from baseline of mean PSG-WASO on N41/N42
6 weeks
Change from baseline of mean PSG-NAW on N41/N42
6 weeks
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
refreshing quality of sleep measured by the patient sleep questionnaire
8 weeks
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 PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS
6 weeks
Patient-reported sleep parameters
6 weeks
Patient Global impression (PGI)
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EplivanserinEXPERIMENTALEplivanserin 5 mg/day
PlaceboPLACEBO_COMPARATORPlacebo of Eplivanserin 5 mg/day
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -
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
EplivanserinDRUGone 5 mg tablet once a day
PlaceboDRUGPlacebo of Eplivanserin one tablet once a day
eplivanserin (SR46349)DRUG5 mg/day
lormetazepamDRUG1 mg/day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria Exclusion Criteria: * Inpatients. * Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening nigh...

Countries:United StatesAustriaCanadaFranceGermanyHungaryPolandChileEstoniaFinlandNetherlandsNorwayPortugalSpainAustraliaArgentinaCzechiaMexicoUnited Kingdom
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Frequently asked questions about Eplivanserin

What is Eplivanserin used for?

Eplivanserin is an investigational small molecule being studied for sleep initiation and maintenance disorders, primary insomnia, and fibromyalgia. It has been evaluated in clinical trials for sleep maintenance insomnia and for sleep disorders associated with fibromyalgia and chronic pain.

Who is developing Eplivanserin?

Eplivanserin is being developed by Sanofi, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker SNY. Sanofi has sponsored multiple clinical trials of Eplivanserin across different patient populations.

What phase is Eplivanserin in?

Eplivanserin has completed Phase 1, Phase 2, and Phase 3 clinical trials. It is an investigational drug and has not been approved by the FDA. Its development status is based on completed trials, with no active trials currently listed.

What clinical trials has Eplivanserin been in?

Eplivanserin has been studied in five completed trials. Key trials include NCT00308503, a Phase 3 study in sleep maintenance insomnia with 608 participants, and NCT00805350, a Phase 3 study in primary insomnia with 637 participants. A Phase 2 trial, NCT00313885, examined its effects in fibromyalgia-related sleep disorders.

Is Eplivanserin the same as SR46349B?

Eplivanserin is also known as SR46349B. One clinical trial, NCT00313885, used the name SR46349B in its title while studying the drug in patients with sleep disorders associated with fibromyalgia.