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Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Study acronym: AmpPT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from MGH Institute of Health Professions

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Phase changed: Phase 4 → Phase 3
    • Primary completion pushed from Aug 2026 to Dec 2026
    v5
  2. Notable Primary completion date: Jan 2026 to Aug 2026
    • Study completion date: Jun 2026 to Dec 2026
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2024 to Jun 12, 2024
    • Site details revised
    v3
  4. Minor Study description expanded, about 2 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06136728
Lead Sponsor MGH Institute of Health Professions
Conditions
(from sponsor)
Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov