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ADS-5102

Phase 3

Walking Impairment | Small molecule | Immunology |Supernus Pharmaceuticals, Inc.|Last Updated: Dec 21, 2021

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment618
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03436199Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking ImpairmentPHASE3 COMPLETED 558 — — Mar 29, 2018Dec 10, 2019Dec 21, 202184 United States, Canada
NCT02471222Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking ImpairmentPHASE2 COMPLETED 60 — — May 1, 2015Jun 1, 2016Aug 8, 201715 United States
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Study Endpoints
Primary Endpoints
Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis)
16 weeks

The T25FW is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.

Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test
Up to 4 weeks
Secondary Endpoints
Timed 25 Foot Walk: Change From Baseline at Week 16
16 weeks
Timed Up and Go (TUG): Change From Baseline at Week 16
16 weeks
2-Minute Walk Test (2MWT): Change From Baseline at Week 16
16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADS-5102, 137 mgEXPERIMENTALADS-5102, administered once daily at bedtime from Week 4 through Week 16
ADS-5102, 274 mgEXPERIMENTALADS-5102, administered once daily at bedtime from Week 4 through Week 16
PlaceboOTHERplacebo, administered once daily at bedtime from Week 4 through Week 16
ADS-5102 (amantadine HCl extended release)EXPERIMENTAL -
Interventions
NameTypeDescription
ADS-5102, 137 mgDRUGOral capsules
ADS-5102, 274 mgDRUGOral capsules
PlaceboOTHEROral capsules
ADS-5102DRUGOral capsules to be administered once daily at bedtime for 4 weeks
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites84

Inclusion Criteria: * Signed a current IRB-approved informed consent form * Male or female subjects between 18 and 70 years of age, inclusive, at the time of Screening * Confirmed diagnosis of MS according to the 2017 McDonald criteria * Current medication regimen must be stable for at least 30 day...

Countries:United StatesCanada
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