Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

NCT06136728 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023P002538
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Timed 25-Foot Walk (T25FW)

  The T25FW is a test that times how long in seconds a person can walk 25 feet from standing start as quickly as possible. We will assess the change in T25FW between baseline and end of treatment for each phase of the treatment (1: dalfampridine only run-in; 1: physical therapy with our without dalfampridine)

  Week 0 to week 6, week 8 to week 14

Study Arms (3)

Dalfampridine only

ACTIVE COMPARATOR

10 mg tablet twice per day

Drug: Dalfampridine 10 MG [Ampyra]

Physical therapy

ACTIVE COMPARATOR

One-on-one outpatient physical therapy twice per week

Behavioral: Physical therapy

Dalfampridine plus physical therapy

ACTIVE COMPARATOR

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

Other: Dalfampridine plus physical therapy

Interventions

Dalfampridine 10 MG [Ampyra] DRUG

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

Also known as: Ampyra

Dalfampridine only

Physical therapy BEHAVIORAL

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

Physical therapy

Dalfampridine plus physical therapy OTHER

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.

Also known as: Combined drug and behavioral

Dalfampridine plus physical therapy

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MGH Institute of Health Professions: lead

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Rehabilitation

Study Officials

• Prudence Plummer, PhD, PT

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prudence Plummer, PhD

CONTACT

617-724-3103; pplummer@mghihp.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: June 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)