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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 : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Walking Impairment Multiple Sclerosis Drug: ADS-5102, 137 mg Drug: ADS-5102, 274 mg Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADS-5102 137 mg Drug: ADS-5102, 137 mg
Oral capsules to be administered once daily at bedtime
Other Names:
  • ADS-5102
  • amantadine HCl extended release

Experimental: ADS-5102 274 mg Drug: ADS-5102, 274 mg
Oral capsules to be administered once daily at bedtime
Other Names:
  • ADS-5102
  • amantadine HCl extended release

Placebo
placebo capsules
Other: Placebo
Oral capsules to be administered once daily at bedtime




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436199


Contacts
Contact: Clinical Trials Administrator 5104503500 clinicaltrials@adamaspharma.com
Contact: Clinical Trials Director Study Director, Adamas Pharmaceuticals, Inc.

  Show 48 Study Locations
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
Study Director: Clinical Trials Director Adamas Pharmaceuticals

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03436199     History of Changes
Other Study ID Numbers: ADS-AMT-MS301
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Amantadine
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents