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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ublituximab
DrugThe participants will receive 48 weeks of treatment with ublituximab.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: UblituximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
slip-fall
The outcome of a slip trial will be deemed a fall if the peak load cell force exceeds 30% of the body weight.
Time frame
48 weeks2
Dynamic gait stability during slip
For a slip, dynamic gait stability will be calculated at two events: the slipping foot touchdown and the recovery foot liftoff.
Time frame
48 weeksSecondary outcomes
1
Dynamic gait stability during walking
Dynamic gait stability during walking will be calculated based on the theoretical framework of Feasible Stability Region.
Time frame
weeks 0, 24, and 482
Spatiotemporal gait parameters during walking
The following parameters will be determined: gait speed, step length, step width, step time, and cadence. These measurements will be used to quantify our participants' ambulatory functions.
Time frame
Weeks 0, 24, and 483
Leg muscle strength
The maximum voluntary muscle strength will be assessed during maximum voluntary contractions at bilateral knee and ankle joints on an isokinetic dynamometer.
Time frame
Weeks 0, 24, and 484
Leg Muscle Activities
The surface electromyography activity from four muscles on each leg: the tibialis anterior (TA), medial gastrocnemius (MGAS), vastus lateralis (VLAT), and biceps femoris long head (BFLH), will be recorded.
Time frame
Weeks 0, 24, and 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgia State University
Lead sponsor
Atlanta Neuroscience Institute
Collaborator
Source ClinicalTrials.gov