Summary

for people ages 18-70 (full criteria)
at Kirkland, Washington and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Multiple Sclerosis Walking Impairment Sclerosis Amantadine ADS-5102

Eligibility

You can join if…

Open to people ages 18-70

  • 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 CAN'T join 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

Locations

  • Adamas Clinical Site accepting new patients
    Kirkland Washington 98034 United States
  • Adamas Clinical Site accepting new patients
    Fort Collins Colorado 80528 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adamas Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT03567057
Phase
Phase 3
Study Type
Interventional
Last Updated