A Study of Experimental Medicine ADS-5102 For Multiple Sclerosis and Walking Impairment

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 to 70 years old
Gender:
Any
Healthy Volunteers: No
Keywords: multiple sclerosis
Type: Drug study, Phase 3
Investigator:
Description
The purpose of this study is to look at the long-term safety and efficiency of experimental ADS-5102. It will be studied in patients with multiple sclerosis (MS) with walking impairment.

"Experimental" means the study drug formulation being tested is not approved by the FDA.

The active ingredient in ADS-5102 is called amantadine. Amantadine is FDA approved to help prevent and treat signs and symptoms of infection caused by some forms of the influenza virus. It is also approved as a treatment for Parkinson’s disease and other nervous system disorders.

ADS-5102 is a formulation of amantadine that allows the drug to be taken up by the body slowly. This kind of formulation is called an extended release (ER) formulation. This allows the drug to be taken once a day.

In MS, neurons of the central nervous system are damaged due to inflammation, and the communication of one neuron to another is impaired. Amantadine may improve the communication between neurons that has been impaired due to MS. Thereby, improve the central nervous system’s control of walking.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will receive $60 for each clinic visit you complete. You will also receive $30 for each study phone call you complete. This is a total of up to $420 for being in this study. This money covers the costs for time spent at the clinic and is to help cover travel expenses to and from the study site.
Resources
Schedule
Study duration and period
Your participation in this study is expected to last about 12 and a half months (12 months of taking the study drug, and 2 weeks of follow-up), and will include up to 6 clinic (study site) visits.
Recruitment period
From July 16, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kelly Wallace
Research Topic
Conditions:
  • Multiple Sclerosis
  • Walking Impairment