A Study to Test the Safety and Effectiveness of Experimental Elezanumab for Relapsing Forms of Multiple Sclerosis

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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 65 years old
Gender:
Any
Healthy Volunteers: No
Keywords: multiple sclerosis, relapsing multiple sclerosis
Type: Drug study, Phase 2
Target:
6 Participants
Investigator:
Description
This study will test the investigational study drug, elezanumab. We hope to learn if it is safe and effective when added to the current treatment in adult subjects with relapsing forms of multiple sclerosis (RMS).

Investigational means that the study drug has not been approved by the FDA. Elezanumab is being studied to determine if it will improve physical functioning in subjects with relapsing forms of MS who have disability.
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:

  • Subject has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months
  • Subject has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS)
  • Subject has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test

Exclusion criteria:

  • Subjects must not have experienced or be recovering from a clinical MS relapse within 6 months of 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
If you agree to take part in this research study, we will compensate you $100 for each study visit you complete, which includes coverage of local travel expenses like meals and mileage. This could total up to $1700 if you complete all study visits. In the event that an unscheduled visit is conducted, you may be paid $40 for the completion of that visit.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 18-19 months (about a year and a half), plus time for screening (up to 4 weeks).
Recruitment period
From Aug. 15, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Multiple Sclerosis (MS)