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Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment

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ClinicalTrials.gov Identifier: NCT03436199
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

February 12, 2018
February 16, 2018
June 12, 2018
March 29, 2018
September 1, 2019   (Final data collection date for primary outcome measure)
Timed 25 foot walk (T25FW, feet/second) [ Time Frame: 12 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. The result is reported as time to complete (seconds) or speed (feet per second). Improvement is indicated by a decrease in time or an increase in speed.
Efficacy of ADS-5102 in subjects with multiple sclerosis with walking impairment as measured by the T25FW, feet/second at Week 12 [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT03436199 on ClinicalTrials.gov Archive Site
  • Timed Up and Go (TUG) [ Time Frame: 12 weeks ]
    The TUG is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
  • 2-Minute Walk Test (2MWT) [ Time Frame: 12 weeks ]
    The 2MWT is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
  • Multiple Sclerosis Walking Scale-12 (MSWS-12) [ Time Frame: 12 weeks ]
    The MSWS-12 is a 12-item walking scale that is a measure of subject-reported walking ability during the past 2 weeks. Each item is scored on a 1 to 5 scale. A total score can be generated and transformed to a 0 to 100 scale. Improvement is indicated by negative change scores.
  • Timed Up and Go [ Time Frame: 12 weeks ]
  • 2-Minute Walk Test [ Time Frame: 12 weeks ]
  • MS Walking Scale-12 [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Walking Impairment
  • Multiple Sclerosis
  • Drug: ADS-5102, 137 mg
    Oral capsules to be administered once daily at bedtime
    Other Names:
    • ADS-5102
    • amantadine HCl extended release
  • Drug: ADS-5102, 274 mg
    Oral capsules to be administered once daily at bedtime
    Other Names:
    • ADS-5102
    • amantadine HCl extended release
  • Other: Placebo
    Oral capsules to be administered once daily at bedtime
  • Experimental: ADS-5102 137 mg
    Intervention: Drug: ADS-5102, 137 mg
  • Experimental: ADS-5102 274 mg
    Intervention: Drug: ADS-5102, 274 mg
  • Placebo
    placebo capsules
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
Same as current
September 1, 2019
September 1, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact: Clinical Trials Administrator 5104503500 clinicaltrials@adamaspharma.com
Contact: Clinical Trials Director Study Director, Adamas Pharmaceuticals, Inc.
United States
 
 
NCT03436199
ADS-AMT-MS301
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
Not Provided
Study Director: Clinical Trials Director Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc.
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP