Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
Condition: Walking Impairment; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ADS-5102, 137 mg; ADS-5102, 274 mg; Placebo
Intervention description: Oral capsules; Oral capsules; Oral capsules
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study assessed the efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg)
      compared with placebo in MS patients with walking impairment.
    

Eligibility criteria:

        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 days prior to screening, and
             subject must be willing to continue the same dosing regimen for the duration of study
             participation

          -  Maximum Expanded Disability Status Scale (EDSS) score during screening of 6.5

          -  Stable physical activity level (inclusive of prescribed physical therapy) for at least
             30 days prior to screening and willing to continue without change for the duration of
             study participation

          -  A score on each of two completed screening T25FW tests between 8 and 45 seconds,
             inclusive

        Exclusion Criteria:

          -  Documented inability to tolerate amantadine

          -  Clinically significant MS relapse with onset less than 30 days prior to screening

          -  Receipt of dalfampridine (or any 4-aminopyridine or 2,4-diaminopyridine preparation)
             or amantadine within 30 days prior to screening

          -  History of seizures within 3 years prior to screening

          -  History of hallucinations (visual, auditory, or any other type) within 3 years prior
             to screening

          -  History of bipolar disorder, schizophrenia, or psychosis, regardless of treatment

          -  For subjects with a history of major depressive disorder, the presence of active
             depressive symptoms that, in the opinion of the investigator, would affect the
             subject's ability to complete study assessments, or which would not be in the
             subject's best interest to participate in the study

          -  Presence of orthostatic hypotension at screening: a decrease in systolic blood
             pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3
             minutes of the subject standing up, compared to pressures obtained while sitting

          -  If female, is pregnant or lactating

          -  If a sexually active female, is not surgically sterile or at least 2 years
             post-menopausal, or does not agree to utilize a highly effective hormonal method of
             contraception (an IUD, or vasectomized male partner is also acceptable), in
             combination with a barrier method, from screening through at least 4 weeks after the
             completion of study treatment. If a sexually active male, does not agree to utilize
             condoms from screening through at least 4 weeks after the completion of study
             treatment.

          -  Treatment with an investigational drug or device within 30 days prior to screening

          -  Treatment with an investigational biologic within 6 months or 5 half-lives, whichever
             is longer, prior to screening