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

• Status: Completed
• Trial end date: 2021-04-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label extension (OLE) study of ADS-5102 (amantadine extended release [ER] capsules) in subjects with MS and walking impairment who completed a prior study of ADS-5102 in subjects with MS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adamas Pharmaceuticals, Inc.
• Treatments: Amantadine

Criteria

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