Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
MGH Institute of Health Professions
Study ID
NCT06136728
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dalfampridine 10 MG [Ampyra] — DRUG
    Dalfampridine (10 mg) every 12 hours for 6 weeks.
  • Physical therapy — BEHAVIORAL
    Physical therapy (motor relearning for mobility and balance) one-on-one twice per week for 6 weeks.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH Institute of Health ProfessionsBostonMassachusetts02129
Prudence Plummer, PhD
[email protected]
617-724-3103
Prudence Plummer, PhD, PT (PRINCIPAL_INVESTIGATOR)
Eric Klawiter, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
MGH Institute of Health Professions· Boston, MA

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