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

NCT03567057 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ADS-AMT-MS303
• Study Type: interventional
• Target: 424
• Locations: 2 countries
• Sites: 92

Brief Summary

This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

Conditions

Multiple Sclerosis; Walking Impairment

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events

  The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.

  Through study completion, an average of 1 year.

Secondary Outcomes (9)

• Timed 25-Foot Walk (Feet/Second) (Baseline Value)

  Baseline

• Timed 25-Foot Walk (Feet/Second) (Week 24 Value)

  24 weeks

• Timed 25-Foot Walk (Feet/Second) (Week 52 Value)

  52 weeks

• Timed up and go (Baseline Value)

  Baseline

• Timed up and go (Week 24 Value)

  24 weeks

Study Arms (1)

ADS-5102, 274 mg

EXPERIMENTAL

274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks

Drug: ADS-5102, 274 mg

Interventions

ADS-5102, 274 mg DRUG

Oral capsules

Also known as: amantadine extended release

ADS-5102, 274 mg

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
• Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

You may not qualify if:

• Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
• 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 baseline 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.
• Anticipated treatment with any amantadine formulation other than ADS-5102
• Planned participation in another interventional clinical trial

Sponsors & Collaborators

• Adamas Pharmaceuticals, Inc.: lead

Study Sites (92)

Adamas Clinical Site

Cullman, Alabama, 35058, United States

Location

Adamas Clinical Site

Phoenix, Arizona, 85018, United States

Location

Adamas Clinical Site

Phoenix, Arizona, 85032, 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, 800209, 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

Miami, Florida, 33176, 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

Location

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

St. Petersburg, Florida, 33713, 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, 66103, 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

Burlington, Massachusetts, 01805, United States

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Adamas Clinical Site

Foxborough, Massachusetts, 02035, United States

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Adamas Clinical Site

Worcester, Massachusetts, 01655, United States

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Adamas Clinical Site

Detroit, Michigan, 42801, 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

Location

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, 68105, United States

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Adamas Clinical Site

Las Vegas, Nevada, 89106, United States

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Adamas Clinical Site

Albuquerque, New Mexico, 87106, United States

Location

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

Location

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, 28204, United States

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Adamas Clinical Site

Raleigh, North Carolina, 27607, United States

Location

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, 97213, 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

Rock Hill, South Carolina, 29732, United States

Location

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

Lubbock, Texas, 79410, United States

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Adamas Clinical Site

Round Rock, Texas, 78681, United States

Location

Adamas Clinical Site

Salt Lake City, Utah, 84103, United States

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Adamas Clinical Site

Newport News, Virginia, 23601, United States

Location

Adamas Clinical Site

Norfolk, Virginia, 23502, United States

Location

Adamas Clinical Site

Kirkland, Washington, 98034, United States

Location

Adamas Clinical Site

Seattle, Washington, 98122, United States

Location

Adamas Clinical Site

Seattle, Washington, 98191, United States

Location

Adamas Clinical Site

Milwaukee, Wisconsin, 53215, United States

Location

Adamas Clinical Site

Edmonton, Alberta, T6G 2G3, Canada

Location

Adamas Clinical Site

Lethbridge, Alberta, T1J 0N9, Canada

Location

Adamas Clinical Site

Burnaby, Brithis Columbia, V5G 2X6, Canada

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Adamas Clinical Site

Vancouver, British Columbia, V6T 2B5, Canada

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Adamas Clinical Site

Hamilton, Ontario, L8L 2X2, Canada

Location

Adamas Clinical Site

London, Ontario, N6A 5A5, Canada

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Adamas Clinical Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Adamas Clinical Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Adamas Clinical Site

Montreal, Quebec, H3A 2B4, Canada

Location

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 Chief Medical Officer, MD

  Adamas Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 25, 2018
• Study Start: July 18, 2018
• Primary Completion: November 17, 2020
• Study Completion: April 18, 2021
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-01

Locations

US (82); CA (10)