Combining dalfampridine with physical therapy to improve walking in multiple sclerosis
Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis
This study is testing if taking dalfampridine along with physical therapy can help people with multiple sclerosis walk better than just using physical therapy alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | MGH Institute of Health Professions Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06136728 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of combining dalfampridine, a medication that enhances walking ability, with a structured physical therapy program in individuals with mobility impairments due to multiple sclerosis (MS). Participants will undergo a 6-week treatment with dalfampridine, followed by a 2-week washout period, after which they will be randomly assigned to receive either physical therapy alone or physical therapy in conjunction with dalfampridine. The study will compare the outcomes of the combined treatment against each individual treatment to determine the most effective approach for improving mobility in MS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with multiple sclerosis who have mobility impairments and meet specific eligibility criteria.
Not a fit: Patients with co-existing neurological disorders, orthopedic conditions affecting mobility, or those currently receiving physical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown positive outcomes with physical therapy in MS, but the combination with dalfampridine is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Boston, Massachusetts
- MGH Institute of Health Professions — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Prudence Plummer, PhD, PT — MGH Institute of Health Professions
- Study coordinator: Prudence Plummer, PhD
- Email: pplummer@mghihp.edu
- Phone: 617-724-3103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.