Dalfampridine + Physical Therapy for Multiple Sclerosis
(AmpPT Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be currently taking dalfampridine or have stopped it due to side effects. You will need to stop dalfampridine for 2 weeks during the trial.
What data supports the effectiveness of the drug dalfampridine combined with physical therapy for improving mobility in people with multiple sclerosis?
Research shows that dalfampridine, when combined with physical therapy, may improve walking speed in people with multiple sclerosis more than physical therapy alone. In a small study, participants taking dalfampridine and doing physical therapy improved their walking speed by about 20.7%, compared to 10.8% for those only doing physical therapy.12345
Is the combination of Dalfampridine and Physical Therapy safe for humans?
Dalfampridine, also known as Ampyra or Fampridine, is generally well tolerated but may increase the risk of seizures, especially in people with kidney problems. Common side effects include urinary tract infections, insomnia, headache, and dizziness. It is important to avoid use in individuals with a history of seizures.46789
How does the treatment of Dalfampridine combined with physical therapy differ from other treatments for multiple sclerosis?
This treatment is unique because it combines Dalfampridine, a drug that helps improve walking by blocking potassium channels in nerve cells, with physical therapy to enhance mobility in people with multiple sclerosis. The combination aims to improve walking speed more effectively than either treatment alone.12478
Research Team
Prudence Plummer, PhD, PT
Principal Investigator
MGH Institute of Health Professions
Eligibility Criteria
This trial is for people with MS who can walk a bit but have trouble with mobility. They should be able to stand on their own and understand instructions, haven't had a relapse in 3 months, and aren't currently on dalfampridine or physical therapy. People with other conditions affecting movement, recent hospital stays, uncontrolled blood pressure or diabetes, history of seizures, kidney issues, or women who are pregnant can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dalfampridine Treatment
Participants receive 6 weeks of dalfampridine treatment to assess the effects of this treatment
Washout and Re-evaluation
Participants stop dalfampridine for 2 weeks and undergo re-evaluation of walking
Physical Therapy with/without Dalfampridine
Participants are randomly assigned to 6 weeks of physical therapy with or without resuming dalfampridine
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dalfampridine
- Physical therapy
Dalfampridine is already approved in United States, European Union for the following indications:
- Improvement of walking in adults with multiple sclerosis
- Improvement of walking in adults with multiple sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
MGH Institute of Health Professions
Lead Sponsor