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

January 12, 2022 updated by: Adamas Pharmaceuticals, Inc.

A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.

All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.

Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.

All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

Study Type

Interventional

Enrollment (Actual)

424

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • Adamas Clinical Site
      • Lethbridge, Alberta, Canada, T1J 0N9
        • Adamas Clinical Site
    • Brithis Columbia
      • Burnaby, Brithis Columbia, Canada, V5G 2X6
        • Adamas Clinical Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Adamas Clinical Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Adamas Clinical Site
      • London, Ontario, Canada, N6A 5A5
        • Adamas Clinical Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Adamas Clinical Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Adamas Clinical Site
      • Montréal, Quebec, Canada, H3A 2B4
        • Adamas Clinical Site
      • Québec City, Quebec, Canada, G1J 1Z4
        • Adamas Clinical Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Adamas Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Adamas Clinical Site
      • Phoenix, Arizona, United States, 85032
        • Adamas Clinical Site
      • Tucson, Arizona, United States, 85704
        • Adamas Clinical Site
    • California
      • Carlsbad, California, United States, 92011
        • Adamas Clinical Site
      • Fresno, California, United States, 93710
        • Adamas Clinical Site
      • Fullerton, California, United States, 92835
        • Adamas Clinical Site
      • Long Beach, California, United States, 90806
        • Adamas Clinical Site
      • Newport Beach, California, United States, 92663
        • Adamas Clinical Site
      • Sacramento, California, United States, 95817
        • Adamas Clinical Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Adamas Clinical Site
      • Colorado Springs, Colorado, United States, 80907
        • Adamas Clinical Site
      • Denver, Colorado, United States, 800209
        • Adamas Clinical Site
      • Fort Collins, Colorado, United States, 80528
        • Adamas Clinical Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Adamas Clinical Site
      • New London, Connecticut, United States, 06320
        • Adamas Clinical Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Adamas Clinical Site
    • Florida
      • Maitland, Florida, United States, 32751
        • Adamas Clinical Site
      • Miami, Florida, United States, 33136
        • Adamas Clinical Site
      • Miami, Florida, United States, 33176
        • Adamas Clinical Site
      • Naples, Florida, United States, 34105
        • Adamas Clinical Site
      • Orlando, Florida, United States, 32806
        • Adamas Clinical Site
      • Ormond Beach, Florida, United States, 32174
        • Adamas Clinical Site
      • Palm Coast, Florida, United States, 32164
        • Adamas Clinical Site
      • Port Charlotte, Florida, United States, 33952
        • Adamas Clinical Site
      • Saint Petersburg, Florida, United States, 33713
        • Adamas Clinical Site
      • Sarasota, Florida, United States, 34233
        • Adamas Clinical Site
      • Tampa, Florida, United States, 33609
        • Adamas Clinical Site
      • Vero Beach, Florida, United States, 32960
        • Adamas Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Adamas Clinical Site
      • Savannah, Georgia, United States, 31406
        • Adamas Clinical Site
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Adamas Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Adamas Clinical Site
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Adamas Clinical Site
      • Lenexa, Kansas, United States, 66214
        • Adamas Clinical Site
      • Overland Park, Kansas, United States, 66212
        • Adamas Clinical Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Adamas Clinical Site
      • Foxboro, Massachusetts, United States, 02035
        • Adamas Clinical Site
      • Worcester, Massachusetts, United States, 01655
        • Adamas Clinical Site
    • Michigan
      • Detroit, Michigan, United States, 42801
        • Adamas Clinical Site
      • Farmington Hills, Michigan, United States, 48334
        • Adamas Clinical Site
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Adamas Clinical Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Adamas Clinical Site
      • Saint Louis, Missouri, United States, 63110
        • Adamas Clinical Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Adamas Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Adamas Clinical Site
      • Omaha, Nebraska, United States, 68105
        • Adamas Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Adamas Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Adamas Clinical Site
    • New York
      • Amherst, New York, United States, 14226
        • Adamas Clinical Site
      • Lake Success, New York, United States, 11042
        • Adamas Clinical Site
      • New York, New York, United States, 10029
        • Adamas Clinical Site
      • Patchogue, New York, United States, 11772
        • Adamas Clinical Site
      • Plainview, New York, United States, 11803
        • Adamas Clinical Site
      • Rochester, New York, United States, 14642
        • Adamas Clinical Site
      • Staten Island, New York, United States, 10306
        • Adamas Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Adamas Clinical Site
      • Raleigh, North Carolina, United States, 27607
        • Adamas Clinical Site
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Adamas Clinical Site
      • Cleveland, Ohio, United States, 44195
        • Adamas Clinical Site
      • Columbus, Ohio, United States, 43214
        • Adamas Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Adamas Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Adamas Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Adamas Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Adamas Clinical Site
      • Greer, South Carolina, United States, 29650
        • Adamas Clinical Site
      • Rock Hill, South Carolina, United States, 29732
        • Adamas Clinical Site
      • Spartanburg, South Carolina, United States, 29307
        • Adamas Clinical Site
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Adamas Clinical Site
      • Franklin, Tennessee, United States, 37064
        • Adamas Clinical Site
      • Johnson City, Tennessee, United States, 37604
        • Adamas Clinical Site
    • Texas
      • Houston, Texas, United States, 77030
        • Adamas Clinical Site
      • Houston, Texas, United States, 77074
        • Adamas Clinical Site
      • Lubbock, Texas, United States, 79410
        • Adamas Clinical Site
      • Round Rock, Texas, United States, 78681
        • Adamas Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Adamas Clinical Site
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Adamas Clinical Site
      • Norfolk, Virginia, United States, 23502
        • Adamas Clinical Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Adamas Clinical Site
      • Seattle, Washington, United States, 98122
        • Adamas Clinical Site
      • Seattle, Washington, United States, 98191
        • Adamas Clinical Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Adamas Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADS-5102, 274 mg
274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
Drug: ADS-5102, 274 mg
Oral capsules
Other Names:
  • amantadine extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events
Time Frame: Through study completion, an average of 1 year.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 25-Foot Walk (Feet/Second) (Baseline Value)
Time Frame: Baseline
The timed 25-foot walk 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 speed (feet per second). Improvement is indicated by an increase in speed.
Baseline
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
Time Frame: 24 weeks
The timed 25-foot walk 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 speed (feet per second). Improvement is indicated by an increase in speed.
24 weeks
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
Time Frame: 52 weeks
The timed 25-foot walk 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 speed (feet per second). Improvement is indicated by an increase in speed.
52 weeks
Timed up and go (Baseline Value)
Time Frame: Baseline
The "timed up and go" 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.
Baseline
Timed up and go (Week 24 Value)
Time Frame: 24 weeks
The "timed up and go" 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.
24 weeks
Timed up and go (Week 52 Value)
Time Frame: 52 weeks
The "timed up and go" 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.
52 weeks
2-Minute Walk Test (Baseline Value)
Time Frame: Baseline
The 2-Minute Walk test 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.
Baseline
2-Minute Walk Test (Week 24 Value)
Time Frame: 24 weeks
The 2-Minute Walk test 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.
24 weeks
2-Minute Walk Test (Week 52 Value)
Time Frame: 52 weeks
The 2-Minute Walk test 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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adamas Pharmaceuticals, Inc.

Investigators

  • Study Director: Clinical Trials Chief Medical Officer, MD, Adamas Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

November 17, 2020

Study Completion (Actual)

April 18, 2021

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADS-AMT-MS303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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