Dalfampridine with Physical Therapy for Multiple Sclerosis

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Recruiting Phase 3 Interventional Study
Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
25 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
MGH Institute of Health Professions · Other
Who this trial is looking for

This trial is looking for people with multiple sclerosis who have difficulty walking. If you join, you'll take a medication called dalfampridine for 6 weeks, have a break from it, and participate in a 6-week physical therapy program.

Are You a Good Fit for This Trial?
Must not be taking Dalfampridine

You may be able to join if

  • I have been diagnosed with multiple sclerosis
  • I have an Expanded Disability Status Scale score of 6.5 or less
  • I can walk 25 feet in 6 to 45 seconds
  • I can stand unsupported for at least 10 seconds
  • I have a Montreal Cognitive Assessment score of 23 or higher
  • I have not had a relapse in at least 3 months
  • I am not currently taking dalfampridine
  • I am not receiving physical therapy

You may not be able to join if

  • I have another neurological or orthopedic condition that affects my mobility
  • I cannot follow a 3-step verbal command in English
  • I have been hospitalized for any reason in the last 3 months
  • I have uncontrolled hypertension or diabetes
  • I have a history of seizures
  • I have renal impairment
  • I am breastfeeding, pregnant, or trying to become pregnant
  • I cannot undergo MRI procedures

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 d…
Trial Locations
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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 c…
Contacts

Prudence Plummer, PhD

617-724-3103

pplummer@mghihp.edu

CONTACT