Recruiting
Phase 3

Dalfampridine & Physical Therapy

Sponsor:

MGH Institute of Health Professions

Code:

NCT06136728

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Dalfampridine 10 MG [Ampyra]

Physical therapy

Dalfampridine plus physical therapy

Study Details

Brief 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

Multiple Sclerosis

Study ID

NCT06136728

Start date

Jun 12, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dalfampridine only

10 mg tablet twice per day

active comparator: Physical therapy

One-on-one outpatient physical therapy twice per week

active comparator: Dalfampridine plus physical therapy

10 mg tablet twice per day while receiving one-on-one outpatient physical therapy twice per week

Interventions

Dalfampridine 10 MG [Ampyra]

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

Physical therapy

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

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.

Primary outcome measure

  • Change in Timed 25-Foot Walk (T25FW) [ Time Frame: Week 0 to week 6, week 8 to week 14 ]

Central Contacts and Locations

Central contacts

Locations

MGH Institute of Health Professions

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Principal Investigator:

Prudence Plummer, PhD, PT

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Jul 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2026-07-20.