Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629428
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People with Relapsing Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
U-PACE
Brief 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
Detailed 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 assessed in terms of their spatiotemporal gait parameters This assessment is considered the baseline test Their disease progression will be evaluated by the neurological exam and serum neurofilament light chain Their cognitive function will be tested by the Montreal Cognitive Assessment Then they will undergo the 48-week ublituximab treatment At the mid-point of the treatment period they will attend another assessment session which is identical to the baseline session Immediately after the 48-week treatment the same assessments will be executed again as the baseline test In addition all participants will experience repeated unexpected slip perturbations while walking on a treadmill under the protection of a full-body safety harness Their response to the the slips will be quantified by their dynamic balance reaction times of the lower leg muscles and adaptation rate to the repeated slips
All the measurements will be analyzed to identify the effects of ublituximab on ambulatory functions disease progression and cognitive status of people with relapsing multiple sclerosis
Our findings will potentially lead to earlier adoption of this highly efficacious disease-modifying treatment and thus likely improve long-term patient care outcomes This study will uncover how ublituximab impacts ambulatory function and mobility among people with relapsing MS This will augment our current understanding of ublituximab which focuses on the aspect of the disease progression Given mobility is critical for people with MS to maintain their employment independence participation in social events and thus the quality of life this study will have great potential to scientifically enhance our scientific understanding of effects of ublituximab and to clinically improve patient care
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 assessed in terms of their spatiotemporal gait parameters This assessment is considered the baseline test Their disease progression will be evaluated by the neurological exam and serum neurofilament light chain Their cognitive function will be tested by the Montreal Cognitive Assessment Then they will undergo the 48-week ublituximab treatment At the mid-point of the treatment period they will attend another assessment session which is identical to the baseline session Immediately after the 48-week treatment the same assessments will be executed again as the baseline test In addition all participants will experience repeated unexpected slip perturbations while walking on a treadmill under the protection of a full-body safety harness Their response to the the slips will be quantified by their dynamic balance reaction times of the lower leg muscles and adaptation rate to the repeated slips
All the measurements will be analyzed to identify the effects of ublituximab on ambulatory functions disease progression and cognitive status of people with relapsing multiple sclerosis
Our findings will potentially lead to earlier adoption of this highly efficacious disease-modifying treatment and thus likely improve long-term patient care outcomes This study will uncover how ublituximab impacts ambulatory function and mobility among people with relapsing MS This will augment our current understanding of ublituximab which focuses on the aspect of the disease progression Given mobility is critical for people with MS to maintain their employment independence participation in social events and thus the quality of life this study will have great potential to scientifically enhance our scientific understanding of effects of ublituximab and to clinically improve patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None