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

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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.


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
Atlanta, Georgia 30309
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Atlanta, GA
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Fairfield, Connecticut 06824
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Fairfield, CT
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Fort Collins, Colorado 80528
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Fort Collins, CO
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12039 Northeast 128th Street
Kirkland, Washington 98034
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Kirkland, WA
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Patchogue, New York 11772
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Patchogue, NY
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