Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis (NCT06136728) | Clinical Trial Compass
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
United States48 participantsStarted 2024-06-12
Plain-language 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.
Who can participate
Age range
25 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
* Unable to follow a 3-step verbal command in English
* Hospitalization for any reason in the last 3 months
* Uncontrolled hypertension or diabetes
* History of seizures
* Renal impairment
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.