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ADS-5102,

Phase 3

Multiple Sclerosis | Small molecule | Immunology |Supernus Pharmaceuticals, Inc.|Last Updated: Jan 18, 2022

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment424
FDA Designations
No designations recorded
Clinical trial landscape

ADS-5102, · 1 trial · 2 indications

Phase 3 1
NCT03567057A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking ImpairmentMultiple Sclerosis
COMPLETED424 Analytics
PHASE3COMPLETED
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Multiple SclerosisUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Patients With Adverse Events
Through study completion, an average of 1 year.

The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.

Secondary Endpoints
Timed 25-Foot Walk (Feet/Second) (Baseline Value)
Baseline
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
24 weeks
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
52 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADS-5102, 274 mgEXPERIMENTAL274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
Interventions
NameTypeDescription
ADS-5102, 274 mgDRUGOral capsules
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites92

Inclusion Criteria: * Signed a current IRB-approved informed consent form * Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment. Exclusion Criteria: * Based on the judgment of the investigator or Medical Monitor, participation in the study would ...

Countries:United StatesCanada
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