NCT06136728 · MGH Institute of Health Professions
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
(AmpPT)
What this study is about
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.
View original scientific 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: * 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.
Interventions
DRUG
Dalfampridine 10 MG [Ampyra]
Dalfampridine (10 mg) every 12 hours for 6 weeks.
BEHAVIORAL
Physical therapy
Physical therapy (motor relearning for mobility and balance) one-on-one twice per week for 6 weeks.
OTHER
Dalfampridine plus physical therapy
Dalfampridine (10 mg) every 12 hours for 6 weeks while simultaneously receiving physical therapy (motor relearning for mobility and balance) one-on-one twice per week.
Primary outcome measures
Change in Timed 25-Foot Walk (T25FW)
Time frame: Week 0 to week 6, week 8 to week 14
The T25FW is a test that times how long in seconds a person can walk 25 feet from standing start as quickly as possible. We will assess the change in T25FW between baseline and end of treatment for each phase of the treatment (1: dalfampridine only run-in; 1: physical therapy with our without dalfampridine)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations