Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGeorgia State University
About this trial
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.
Eligibility criteria
Qualifiers
Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
Ages between 18 and 55 years old at screening.
Clinically confirmed active, relapsing forms of MS based on the revised McDonald criteria.
Can walk at least 25 feet independently with or without assistive devices at screening.
Disqualifiers
History of MS types other than relapsing MS at screening (such as primary-progressive MS, inactive SPMS).
History of life-threatening infusion reaction on ublituximab, any of its ingredients, or prior anti-clusters of differentiation 20 (CD20) therapy.
Hypersensitive to any of the ingredients of ublituximab.
Do not understand English.
Trial design
Treatments tested in this trial
- Ublituximab
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Georgia State University
Lead sponsor
Atlanta Neuroscience Institute
Collaborator
Source ClinicalTrials.gov