Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People With Relapsing Multiple Sclerosis
Georgia State University
Summary
The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.
Description
The primary objective of this single-arm and pretest-posttest study will be to examine the effects of treatment with ublituximab on ambulatory functions during unperturbed walking and large-scale gait slips (dynamic gait stability and slip-fall) among people with relapsing MS over a 12-month treatment period. Additionally, the effects of ublituximab on disease progression and cognitive functions will be evaluated. Twenty-five qualified people with relapsing multiple sclerosis (RMS) will be enrolled to this study. Before the treatment, their ambulatory functions during regular walking will be…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments. 2. Ages between 18 and 55 years old at screening. 3. Clinically confirmed active, relapsing forms of MS based on the revised McDonald criteria. 4. Can walk at least 25 feet independently with or without assistive devices at screening. 5. Can stand independently for at least 30 seconds. 6. Not pregnant at screening and throughout the study. * A negative urine or serum pregnancy test must be available for premenopausal women and for women \< 12 months aft…
Interventions
- DrugUblituximab
The participants will receive 48 weeks of treatment with ublituximab.
Locations (2)
- Georgia State UniversityAtlanta, Georgia
- Atlanta Neuroscience InstituteAtlanta, Georgia