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

• ClinicalTrials.gov Identifier: NCT03436199
• Recruitment Status: Recruiting
• First Posted: February 16, 2018
• Last Update Posted: August 2, 2018
• Sponsor: Adamas Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Adamas Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: February 12, 2018
• First Posted Date: February 16, 2018
• Last Update Posted Date: August 2, 2018
• Actual Study Start Date: March 29, 2018
• Estimated Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 7, 2018)

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.

• Original Primary Outcome Measures (submitted: February 12, 2018): 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 ]
• Change History: Complete list of historical versions of study NCT03436199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: March 7, 2018)

• 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.

Original Secondary Outcome Measures (submitted: February 12, 2018)

• Timed Up and Go [ Time Frame: 12 weeks ]
• 2-Minute Walk Test [ Time Frame: 12 weeks ]
• MS Walking Scale-12 [ Time Frame: 12 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Walking Impairment
• Multiple Sclerosis

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 12, 2018): 540
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2019
• Estimated Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trials Administrator; 5104503500; clinicaltrials@adamaspharma.com

Contact: Clinical Trials Director Study Director, Adamas Pharmaceuticals, Inc.

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03436199
• Other Study ID Numbers: ADS-AMT-MS301
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Adamas Pharmaceuticals, Inc.
• Study Sponsor: Adamas Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials Director; Adamas Pharmaceuticals

• PRS Account: Adamas Pharmaceuticals, Inc.
• Verification Date: July 2018