NCT06136728RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 13 Nov 2023
- Start date
- 12 Jun 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- MGH Institute of Health Professions
- Diseases
- Multiple sclerosis
- NCT number
- NCT06136728
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 48
- From 12 Jun 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
- Uncontrolled hypertension or diabetes
- History of seizures
- Renal impairment
Other
- Unable to follow a 3-step verbal command in English
- Hospitalization for any reason in the last 3 months
- 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)
Who the study is looking for
- 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
Age in the registry: 25 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MGH Institute of Health Professions Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.