Dalfampridine with Physical Therapy for Multiple Sclerosis
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Recruiting
Phase 3Interventional Study
Multiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
25 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
MGH Institute of Health Professions · Other
Who this trial is looking for
This trial is looking for people with multiple sclerosis who have difficulty walking. If you join, you'll take a medication called dalfampridine for 6 weeks, have a break from it, and participate in a 6-week physical therapy program.
Are You a Good Fit for This Trial?
Must not be takingDalfampridine
You may be able to join if
I have been diagnosed with multiple sclerosis
I have an Expanded Disability Status Scale score of 6.5 or less
I can walk 25 feet in 6 to 45 seconds
I can stand unsupported for at least 10 seconds
I have a Montreal Cognitive Assessment score of 23 or higher
I have not had a relapse in at least 3 months
I am not currently taking dalfampridine
I am not receiving physical therapy
You may not be able to join if
I have another neurological or orthopedic condition that affects my mobility
I cannot follow a 3-step verbal command in English
I have been hospitalized for any reason in the last 3 months
I have uncontrolled hypertension or diabetes
I have a history of seizures
I have renal impairment
I am breastfeeding, pregnant, or trying to become pregnant
I cannot undergo MRI procedures
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 d…
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.
Trial Locations
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Eligibility Criteria
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 c…
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)
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