Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People With Relapsing Multiple Sclerosis
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.
• 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.
• Can stand independently for at least 30 seconds.
• 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 after the onset of menopause at screening, unless they have undergone surgical sterilization.
⁃ Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of \< 1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment.
• A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the ovaries and/or uterus).
∙ Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tube ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
∙ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.
∙ Examples of barrier methods supplemented with the use of spermicide include male or female condom, vaginal ring, cap, diaphragm, or sponge.
• No other neurological conditions and recent musculoskeletal injuries.
• Can read and understand English.
• No significant cognitive impairment.