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

NCT05859802 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: RMD0690511A
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Dalfampridine; Functional Mobility; Non ambulatory; Cognition; Quality of Life

Outcome Measures

Primary Outcomes (6)

• MSQOL -54

  Baseline

• MSQOL -54

  6 weeks

• MSQOL -54

  12 weeks

• Five time Sit to Stand

  Baseline

• Five time Sit to Stand

  6 weeks

• Five time Sit to Stand

  12 weeks

Secondary Outcomes (12)

• Symbol Digit Modalities Test

  Baseline

• Symbol Digit Modalities Test

  6 weeks

• Symbol Digit Modalities Test

  12 weeks

• Wheel chair to Mat transfers - Functional Independence Measure

  Baseline

• Wheel chair to Mat transfers - Functional Independence Measure

  6 weeks

Study Arms (2)

Drug Group

EXPERIMENTAL

Drug: Dalfampridine Pill

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dalfampridine Pill DRUG

Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day

Also known as: Physical Therapy

Drug Group

Placebo DRUG

Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day

Placebo Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D'Youville College: lead
• Acorda Therapeutics: collaborator
• University at Buffalo: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy for 12 weeks while taking Dalfampradine 10 mg two times day and Group 2 received physical therapy while taking a placebo pill two times a day. Both investigators that were preforming the testing and treatment were blinded as to subject group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 16, 2023
• Study Start: July 13, 2011
• Primary Completion: March 3, 2015
• Study Completion: January 9, 2016
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share