Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis

D'Youville College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Dalfampridine Pill; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05859802

RMD0690511A

Details and patient eligibility

About

The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are:

1. Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone
2. Does Physical Therapy improve functional outcomes in patients who are non ambulatory

Full description

This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS.

Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility.

Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20 years or older confirmed MS diagnosis
• Expanded Disability Status Scale (EDSS) of 7.0 or higher
• No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable
• Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups

Exclusion criteria

• History of seizure disorder
• Major cognitive or mental illness that prevented their ability to provide consent
• Evidence of other medical cause of cognitive impairment besides MS
• Severe joint contractures that limited the patients ability to move within full active range of motion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Drug Group

Experimental group

Treatment:

Drug: Dalfampridine Pill

Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo