A Study of the Safety and Effectiveness of Experimental ADS-5102 For Multiple Sclerosis With Walking Impairment
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"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, multiple sclerosis with walking impairment
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This study will test the effectiveness, safety, and tolerability of the experimental drug ADS-5102. It will be tested in people with difficulty walking caused by multiple sclerosis (MS).

"Experimental" means the study drug is not approved by the FDA for this condition.

The active ingredient in ADS-5102 is called amantadine. Amantadine is FDA approved for other conditions.

ADS-5102 is a formulation of amantadine that allows the drug to be taken up by the body slowly after it is swallowed. This kind of formulation is called an extended release (ER) formulation and allows the drug to be taken once a day.
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
  • Male or female subjects between 18 and 70 years of age, inclusive, at the time of Screening
  • Confirmed diagnosis of MS according to the 2017 McDonald criteria
  • Current medication regimen must be stable for at least 30 days prior to screening, and subject must be willing to continue the same dosing regimen for the duration of study participation
  • Maximum Expanded Disability Status Scale (EDSS) score during screening of 6.5
  • Stable physical activity level (inclusive of prescribed physical therapy) for at least 30 days prior to screening and willing to continue without change for the duration of study participation
  • A score on each of two completed screening T25FW tests between 8 and 45 seconds, inclusive

Exclusion criteria:

  • Documented inability to tolerate amantadine
  • Clinically significant MS relapse with onset less than 30 days prior to screening
  • Receipt of dalfampridine (or any 4-aminopyridine or 2,4-diaminopyridine preparation) or amantadine within 30 days prior to screening
  • History of seizures within 3 years prior to screening
  • History of hallucinations (visual, auditory, or any other type) within 3 years prior to screening
  • History of bipolar disorder, schizophrenia, or psychosis, regardless of treatment
  • For subjects with a history of major depressive disorder, the presence of active depressive symptoms that, in the opinion of the investigator, would affect the subject's ability to complete study assessments, or which would not be in the subject's best interest to participate in the study
  • Presence of orthostatic hypotension at screening: a decrease in systolic blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3 minutes of the subject standing up, compared to pressures obtained while sitting
  • 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 screening 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.
  • Treatment with an investigational drug or device within 30 days prior to screening
  • Treatment with an investigational biologic within 6 months or 5 half-lives, whichever is longer, prior to screening
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 $600 for being in this study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for about 5 months. This includes up to 3 weeks for screening, 16 weeks of taking the study drug or placebo, and 2 weeks of follow-up. You will have up to 9 clinic (study site) visits.
Recruitment period
From May 21, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kelly Wallace
Research Topic
Conditions:
  • Walking Impairment
  • Multiple Sclerosis