Actively Recruiting
Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Led by Georgia State University · Updated on 2026-02-09
25
Participants Needed
2
Research Sites
59 weeks
Total Duration
On this page
Sponsors
G
Georgia State University
Lead Sponsor
A
Atlanta Neuroscience Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written, informed consent and comply with study assessments
- Age between 18 and 55 years at screening
- Clinically confirmed active relapsing forms of multiple sclerosis based on revised McDonald criteria
- Ability to walk at least 25 feet independently with or without assistive devices
- Ability to stand independently for at least 30 seconds
- Not pregnant at screening and during the study; negative pregnancy test required for premenopausal women and women less than 12 months post-menopause unless surgically sterilized
- Women of childbearing potential must agree to abstain from heterosexual intercourse or use effective contraception during treatment and for 6 months after last dose
- No other neurological conditions or recent musculoskeletal injuries
- Ability to read and understand English
- No significant cognitive impairment
You will not qualify if you...
- History of multiple sclerosis types other than relapsing MS (e.g., primary-progressive MS, inactive secondary-progressive MS)
- History of life-threatening infusion reaction to ublituximab or related therapies
- Hypersensitivity to ublituximab ingredients
- Inability to understand English
- Pregnancy or breastfeeding
- Other neurological diseases that mimic MS (e.g., neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency)
- History of significant central nervous system trauma
- History of liver disease
- Active hepatitis B infection
- Current or known history of significant infection
- Coexisting psychiatric, neurological, or severe medical illnesses
- Severe depression or suicidal ideation
- Significant cognitive impairment (MoCA score less than 24)
- Recent unstable orthopedic conditions
- History or active immunodeficiency
- Receipt of live vaccines within 6 weeks before baseline
- Skin allergy to transparent double-sided tapes
- Diseases requiring chronic systemic corticosteroids or immunosuppressants
- Lack of peripheral venous access
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Significant or uncontrolled somatic disease
- Congestive heart failure (NYHA III or IV)
- Active bacterial, viral, fungal, or mycobacterial infections except nail bed fungal infections
- Recent infections requiring hospitalization or antibiotics
- History or presence of chronic infections (e.g., hepatitis B or C, HIV, syphilis, tuberculosis)
- History of progressive multifocal leukoencephalopathy
- History of malignancy except certain skin and cervical cancers fully excised
- History of alcohol or drug abuse within 24 weeks prior to baseline
- History or lab evidence of coagulation disorders
- Use of live or live-attenuated vaccines within 4 weeks prior to first treatment
- Treatment with investigational agents within 24 weeks or five half-lives
- Systemic corticosteroids within 4 weeks prior to screening
- Previous treatments with certain immunotherapies and chemotherapies within specified time frames
- Inability to walk at least 25 feet or stand for 30 seconds independently
- Vision impairments affecting walking ability
- Recent broken bones or neurological treatments
- Recent major heart procedures
- Recent major surgeries or joint replacements
- Unstable or untreated respiratory conditions
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Georgia State University
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
2
Atlanta Neuroscience Institute
Atlanta, Georgia, United States, 30327
Actively Recruiting
Research Team
M
Mittie Mitchell, RN, CRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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