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NCT06136728 · ClinicalTrials.gov registry record · Phase 4
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
A Phase 4 study of Multiple Sclerosis, sponsored by MGH Institute of Health Professions.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06136728: Recruiting Phase 4 study of Multiple Sclerosis, sponsored by MGH Institute of Health Professions.
NCT06136728 is a Phase 4 study of Multiple Sclerosis that is actively recruiting participants, run by MGH Institute of Health Professions. The registered enrollment target is 48 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06136728, a Phase 4 study of Multiple Sclerosis, is actively recruiting participants, sponsored by MGH Institute of Health Professions.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Dalfampridine 10 MG [Ampyra]
- BEHAVIORAL Physical therapy
- OTHER Dalfampridine plus physical therapy
Study Locations (1)
Massachusetts
- MGH Institute of Health Professions - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT06136728 shows while recruiting
NCT06136728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Dalfampridine 10 MG [Ampyra] is the first listed.
NCT06136728 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06136728 about?
NCT06136728 is a clinical study titled "Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis". 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 ...
What is the current status of trial NCT06136728?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2024-06-12. Estimated completion is 2026-12.
What conditions does trial NCT06136728 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT06136728?
The interventions under investigation include: Dalfampridine 10 MG [Ampyra] (DRUG), Physical therapy (BEHAVIORAL), Dalfampridine plus physical therapy (OTHER).
Who is sponsoring clinical trial NCT06136728?
This trial is sponsored by MGH Institute of Health Professions, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06136728 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06136728's enrollment target sits among peer trials
48 187th of 315 higher than 128 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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