A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 9/5/2018 |
Start Date: | July 18, 2018 |
End Date: | January 2021 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrials@adamaspharma.com |
Phone: | 5104503500 |
A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
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.
release [ER] capsules) in subjects with MS and walking impairment who completed a prior study
of ADS-5102 in subjects with MS.
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
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials