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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Walking Impairment

In brief

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).

Key facts

Study ID

NCT03567057

Run by

Adamas Pharmaceuticals, Inc.

People needed

424

Starts

2018-07-18

Expected to finish

2021-04-18

Last updated by the study team

2022-01-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Adamas Clinical Site — Phoenix, Arizona, United States
• Adamas Clinical Site — Phoenix, Arizona, United States
• Adamas Clinical Site — Tucson, Arizona, United States
• Adamas Clinical Site — Carlsbad, California, United States
• Adamas Clinical Site — Fresno, California, United States
• Adamas Clinical Site — Fullerton, California, United States
• Adamas Clinical Site — Long Beach, California, United States
• Adamas Clinical Site — Newport Beach, California, United States
• Adamas Clinical Site — Sacramento, California, United States
• Adamas Clinical Site — Aurora, Colorado, United States
• Adamas Clinical Site — Colorado Springs, Colorado, United States
• Adamas Clinical Site — Denver, Colorado, United States
• Adamas Clinical Site — Fort Collins, Colorado, United States
• Adamas Clinical Site — Fairfield, Connecticut, United States
• Adamas Clinical Site — New London, Connecticut, United States
• Adamas Clinical Site — Washington D.C., District of Columbia, United States
• Adamas Clinical Site — Maitland, Florida, United States
• Adamas Clinical Site — Miami, Florida, United States
• Adamas Clinical Site — Miami, Florida, United States
• Adamas Clinical Site — Naples, Florida, United States
• Adamas Clinical Site — Orlando, Florida, United States
• Adamas Clinical Site — Ormond Beach, Florida, United States
• Adamas Clinical Site — Palm Coast, Florida, United States
• Adamas Clinical Site — Port Charlotte, Florida, United States
• Adamas Clinical Site — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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