Status:
COMPLETED
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
Lead Sponsor:
Adamas Pharmaceuticals, Inc.
Conditions:
Walking Impairment
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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.
Detailed Description
This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking impairment. The study c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2019
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT03436199
Start Date
March 29 2018
End Date
December 10 2019
Last Update
December 21 2021
Active Locations (84)
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1
Adamas Clinical Site
Cullman, Alabama, United States, 35058
2
Adamas Clinical Site
Phoenix, Arizona, United States, 85032
3
Adamas Clinical Site
Scottsdale, Arizona, United States, 85251
4
Adamas Clinical Site
Tucson, Arizona, United States, 85704