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

NCT03436199 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ADS-AMT-MS301
• Study Type: interventional
• Target: 558
• Locations: 2 countries
• Sites: 84

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.

Conditions

Walking Impairment; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis)

  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. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.

  16 weeks

Secondary Outcomes (3)

• Timed 25 Foot Walk: Change From Baseline at Week 16

  16 weeks

• Timed Up and Go (TUG): Change From Baseline at Week 16

  16 weeks

• 2-Minute Walk Test (2MWT): Change From Baseline at Week 16

  16 weeks

Study Arms (3)

ADS-5102, 137 mg

EXPERIMENTAL

ADS-5102, administered once daily at bedtime from Week 4 through Week 16

Drug: ADS-5102, 137 mg

ADS-5102, 274 mg

EXPERIMENTAL

ADS-5102, administered once daily at bedtime from Week 4 through Week 16

Drug: ADS-5102, 274 mg

Placebo

OTHER

placebo, administered once daily at bedtime from Week 4 through Week 16

Other: Placebo

Interventions

ADS-5102, 137 mg DRUG

Oral capsules

Also known as: ADS-5102, amantadine extended release

ADS-5102, 137 mg

ADS-5102, 274 mg DRUG

Oral capsules

Also known as: ADS-5102, amantadine extended release

ADS-5102, 274 mg

Placebo OTHER

Oral capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Adamas Pharmaceuticals, Inc.: lead

Study Sites (84)

Adamas Clinical Site

Cullman, Alabama, 35058, United States

Location

Adamas Clinical Site

Phoenix, Arizona, 85032, United States

Location

Adamas Clinical Site

Scottsdale, Arizona, 85251, United States

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Adamas Clinical Site

Tucson, Arizona, 85704, United States

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Adamas Clinical Site

Carlsbad, California, 92011, United States

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Adamas Clinical Site

Fresno, California, 93710, United States

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Adamas Clinical Site

Fullerton, California, 92835, United States

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Adamas Clinical Site

Long Beach, California, 90806, United States

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Adamas Clinical Site

Newport Beach, California, 92663, United States

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Adamas Clinical Site

Sacramento, California, 95817, United States

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Adamas Clinical Site

Aurora, Colorado, 80045, United States

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Adamas Clinical Site

Colorado Springs, Colorado, 80907, United States

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Adamas Clinical Site

Denver, Colorado, 80209, United States

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Adamas Clinical Site

Fort Collins, Colorado, 80528, United States

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Adamas Clinical Site

Fairfield, Connecticut, 06824, United States

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Adamas Clinical Site

New London, Connecticut, 06320, United States

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Adamas Clinical Site

Washington D.C., District of Columbia, 20007, United States

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Adamas Clinical Site

Maitland, Florida, 32751, United States

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Adamas Clinical Site

Miami, Florida, 33136, United States

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Adamas Clinical Site

Naples, Florida, 34105, United States

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Adamas Clinical Site

Orlando, Florida, 32806, United States

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Adamas Clinical Site

Ormond Beach, Florida, 32174, United States

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Adamas Clinical Site

Palm Coast, Florida, 32164, United States

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Adamas Clinical Site

Port Charlotte, Florida, 33952, United States

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Adamas Clinical Site

Sarasota, Florida, 34233, United States

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Adamas Clinical Site

Tampa, Florida, 33609, United States

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Adamas Clinical Site

Vero Beach, Florida, 32960, United States

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Adamas Clinical Site

Atlanta, Georgia, 30309, United States

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Adamas Clinical Site

Savannah, Georgia, 31406, United States

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Adamas Clinical Site

Northbrook, Illinois, 60062, United States

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Adamas Clinical Site

Indianapolis, Indiana, 46256, United States

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Adamas Clinical Site

Kansas City, Kansas, 66160, United States

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Adamas Clinical Site

Lenexa, Kansas, 66214, United States

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Adamas Clinical Site

Overland Park, Kansas, 66212, United States

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Adamas Clinical Site

Foxborough, Massachusetts, 02035, United States

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Adamas Clinical Site

Lexington, Massachusetts, 02421, United States

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Admas Clinical Site

Detroit, Michigan, 48201, United States

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Adamas Clinical Site

Farmington Hills, Michigan, 48334, United States

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Adamas Clinical Site

Golden Valley, Minnesota, 55422, United States

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Adamas Clinical Site

Kansas City, Missouri, 64111, United States

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Adamas Clinical Site

St Louis, Missouri, 63110, United States

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Adamas Clinical Site

Great Falls, Montana, 59405, United States

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Adamas Clinical Site

Lincoln, Nebraska, 68506, United States

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Adamas Clinical Site

Omaha, Nebraska, 68198, United States

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Adamas Clinical Site

Las Vegas, Nevada, 89016, United States

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Adamas Clinical Site

Albuquerque, New Mexico, 87131, United States

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Adamas Clinical Site

Amherst, New York, 14226, United States

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Adamas Clinical Site

Lake Success, New York, 11042, United States

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Adamas Clinical Site

New York, New York, 10029, United States

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Adamas Clinical Site

Patchogue, New York, 11772, United States

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Adamas Clinical Site

Plainview, New York, 11803, United States

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Adamas Clinical Site

Rochester, New York, 14642, United States

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Adamas Clinical Site

Staten Island, New York, 10306, United States

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Adamas Clinical Site

Charlotte, North Carolina, 28207, United States

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Adamas Clinical Site

Raleigh, North Carolina, 27607, United States

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Adamas Clinical Site

Centerville, Ohio, 45459, United States

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Adamas Clinical Site

Cleveland, Ohio, 44195, United States

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Adamas Clinical Site

Columbus, Ohio, 43214, United States

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Adamas Clinical Site

Oklahoma City, Oklahoma, 73104, United States

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Adamas Clinical Site

Portland, Oregon, 97225, United States

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Adamas Clinical Site

Philadelphia, Pennsylvania, 19140, United States

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Adamas Clinical Site

Charleston, South Carolina, 29406, United States

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Adamas Clinical Site

Greer, South Carolina, 29650, United States

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Adamas Clinical Site

Old Point Station, South Carolina, 29707, United States

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Adamas Clinical Site

Spartanburg, South Carolina, 29307, United States

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Adamas Clinical Site

Cordova, Tennessee, 38018, United States

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Adamas Clinical Site

Franklin, Tennessee, 37064, United States

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Adamas Clinical Site

Johnson City, Tennessee, 37604, United States

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Adamas Clinical Site

Houston, Texas, 77030, United States

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Adamas Clinical Site

Houston, Texas, 77074, United States

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Adamas Clinical Site

Round Rock, Texas, 78681, United States

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Adamas Clinical Site

Salt Lake City, Utah, 84103, United States

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Adamas Clinical Site

Newport News, Virginia, 23601, United States

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Adamas Clinical Site

Norfolk, Virginia, 23502, United States

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Adamas Clinical Site

Kirkland, Washington, 98034, United States

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Adamas Clinical Site

Seattle, Washington, 98101, United States

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Adamas Clinical Site

Seattle, Washington, 98122, United States

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Adamas Clinical Site

Milwaukee, Wisconsin, 53215, United States

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Adamas Clinical Site

Edmonton, Alberta, T6R 2B7, Canada

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Adamas Clinical Site

Lethbridge, Alberta, T1J 0N9, Canada

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Adamas Clinical Site

Burnaby, British Columbia, V5G 2X6, Canada

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Adamas Clinical Site

Greenfield Park, Quebec, J4V 2J2, Canada

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Adamas Clinical Site

Montreal, Quebec, H3A 2B4, Canada

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Adamas Clinical Site

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Head, Regulatory Affairs
• Organization: Adamas Pharmaceuticals, Inc.

drugsafety@adamaspharma.com

+1 (510) 450-3500

Study Officials

• Clinical Trials Director

  Adamas Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: March 29, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-12

Locations

US (78); CA (6)