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Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

NCT06136728 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-27

No results posted yet for this study

Summary

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

Interventions

DRUG

Dalfampridine 10 MG [Ampyra]

Dalfampridine (10 mg) every 12 hours for 6 weeks.

BEHAVIORAL

Physical therapy

Physical therapy (motor relearning for mobility and balance) one-on-one twice per week for 6 weeks.

OTHER

Dalfampridine plus physical therapy

Dalfampridine (10 mg) every 12 hours for 6 weeks while simultaneously receiving physical therapy (motor relearning for mobility and balance) one-on-one twice per week.

Sponsors & Collaborators

  • MGH Institute of Health Professions

    lead OTHER

Principal Investigators

  • Prudence Plummer, PhD, PT · MGH Institute of Health Professions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06136728 on ClinicalTrials.gov