Actively Recruiting

Phase 4
Age: 25Years - 75Years
All Genders
NCT06136728

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Led by MGH Institute of Health Professions · Updated on 2026-02-27

48

Participants Needed

1

Research Sites

128 weeks

Total Duration

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AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Who Can Participate

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of MS
  • Expanded Disability Status Scale (EDSS) 6.5 or less
  • Timed 25-Foot Walk between 6 and 45 seconds (average of 2 trials)
  • Able to stand unsupported for at least 10 seconds
  • Montreal Cognitive Assessment score of 23 or higher
  • No MS relapse for at least 3 months
  • Not currently taking dalfampridine or have not stopped it due to adverse reactions
  • Not currently receiving physical therapy
Not Eligible

You will not qualify if you...

  • Other neurological disorders or orthopedic conditions affecting mobility and physical activity
  • Unable to follow a 3-step verbal command in English
  • Hospitalized for any reason in the last 3 months
  • Uncontrolled high blood pressure or diabetes
  • History of seizures
  • Kidney problems
  • Women who are breastfeeding, pregnant, or trying to become pregnant
  • Contraindications to MRI (excluded from MRI procedures but may participate if other criteria are met)

AI-Screening

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Trial Site Locations

Total: 1 location

1

MGH Institute of Health Professions

Boston, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

P

Prudence Plummer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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