Summary

for people ages 18-70 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

This is a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine extended release [ER] capsules) in MS patients with walking impairment. ADS-5102 will be administered once daily at bed time.

Official Title

A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment

Keywords

Walking Impairment Multiple Sclerosis Sclerosis Amantadine ADS-5102, 137 mg ADS-5102, 274 mg ADS-5102 137 mg ADS-5102 274 mg

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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

Locations

  • Adamas Clinical Site accepting new patients
    Sacramento California 95817 United States
  • Adamas Clinical Site accepting new patients
    Fresno California 93710 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adamas Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT03436199
Phase
Phase 3
Study Type
Interventional
Last Updated