Status:
RECRUITING
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Lead Sponsor:
MGH Institute of Health Professions
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief 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 wa...
Detailed Description
Multiple sclerosis (MS) is a degenerative disease process that disrupts the transmission of nerve impulses, resulting in a range of neurological signs and symptoms. Walking-related impairment is one o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06136728
Start Date
June 12 2024
End Date
June 1 2026
Last Update
December 19 2024
Active Locations (1)
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1
MGH Institute of Health Professions
Boston, Massachusetts, United States, 02129