Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: * Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine? * Is the combined treatment associated with better outcomes than the medication (dalfampridine) on its own? * How do the individual treatments (dalfampridine, physical therapy) alone compare to each other? Participants with MS-related mobility deficits will: * Receive 6 weeks of dalfampridine treatment to assess the effects of this treatment. * After stopping the medication for 2 weeks, the investigators will re-evaluate walking, then randomly assign individuals to a 6-week physical therapy program. * Half of the participants will receive physical therapy while resuming dalfampridine treatment. The other half of the participants will receive physical therapy without resuming the medication. Researchers will compare the combination treatment group (medication plus physical therapy) to the physical therapy only group to see if the combined treatment improves walking-related function. Approximately 3 months after finishing the physical therapy program, participants will undergo a final evaluation to see if the treatment effects have been maintained.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 75
Healthy Volunteers: f
View:

• Confirmed diagnosis of MS

• Expanded Disability Status Scale (EDSS) 6.5 or less

• Timed 25-Foot Walk 6-45 seconds (average of 2 trials)

• Able to stand unsupported for at least 10 seconds

• Montreal Cognitive Assessment 23 or higher

• Relapse free for at least 3 months

• Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions

• Not currently receiving physical therapy

Locations
United States
Massachusetts
MGH Institute of Health Professions
RECRUITING
Boston
Contact Information
Primary
Prudence Plummer, PhD
pplummer@mghihp.edu
617-724-3103
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2026-06
Participants
Target number of participants: 48
Treatments
Active_comparator: Dalfampridine only
10 mg tablet twice per day
Active_comparator: Physical therapy
One-on-one outpatient physical therapy twice per week
Active_comparator: Dalfampridine plus physical therapy
10 mg tablet twice per day while receiving one-on-one outpatient physical therapy twice per week
Related Therapeutic Areas
Sponsors
Leads: MGH Institute of Health Professions

This content was sourced from clinicaltrials.gov