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Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether dalfampridine, a medicine that can help walking, works better with physical therapy than either treatment alone. It is for people with multiple sclerosis (MS) who have trouble walking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of MS.
  • Score 6.5 or less on the EDSS, a scale that measures disability from MS.
  • Walk 25 feet in 6–45 seconds, based on the average of 2 tries.
  • Stand without support for at least 10 seconds.
  • Score at least 23 on the Montreal Cognitive Assessment, a test of memory and thinking.
  • Have had no MS flare-ups for at least 3 months.
  • Are not taking dalfampridine now and have not stopped it in the past because of side effects.
  • Are not receiving physical therapy now.

Who can't join

  • Have another brain, nerve, bone, or joint condition that affects walking and physical activity.
  • Cannot follow a spoken 3-step instruction in English.
  • Have been in the hospital for any reason in the past 3 months.
  • Have high blood pressure or diabetes that is not controlled.
  • Have ever had seizures.
  • Have kidneys that do not work well.
  • Are breastfeeding, pregnant, or trying to become pregnant.
  • Cannot safely have an MRI scan. This only rules out the MRI part; you may still join if you meet all other rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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)

Study sites (1)

MA