Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-75
SponsorMGH Institute of Health Professions

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dalfampridine 10 MG [Ampyra]
  • Physical therapy
  • Dalfampridine plus physical therapy

Treatment groups

48 Participants
are divided into 3 treatment groups