Tests dalfampridine with physical therapy for walking problems in multiple sclerosis
Tests whether a walking medicine plus physical therapy helps people with multiple sclerosis walk better.
Plain-language title generated from the registry record
Registry title: Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 75 years old?
Source: NCT06136728, who can take part
Where in United States
- MGH Institute of Health ProfessionsBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MGH Institute of Health Professions
- Trial code
- NCT06136728
- Record updated
- 6 November 2026
- Original description
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:Read full original descriptionShow less
Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis
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.
Inclusion: 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.
Exclusion: Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity; Uncontrolled hypertension or diabetes; History of seizures; Renal impairment; Unable to follow a 3-step verbal command in English; Hospitalization for any reason in the last 3 months; Women who are breastfeeding, pregnant, or trying to become pregnant; Contraindications to magnetic resonance imaging (MRI; to be excluded from MRI procedures but may participate if all other criteria are met).