Use of Dalfampridin in Primary Lateral Sclerosis

Purpose

This study will comprise an 18-week open label safety and tolerability trial. In this study, a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate ALS will be enrolled. View more study details on ClinicalTrials.gov.

Procedures

  • At the initial screening evaluation, a baseline "Timed 25 Foot Walk" test will be obtained. This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. 
  • A consistent responder will be defined as improvement in 3 out of 4 "Timed 25 Foot Walk" while on medication, compared with the baseline results while off medication.

For more details about study procedures, please contact Rebecca Zelmanovich:

Eligibility 

  • Diagnosis of upper motor neuron disease, compatible with PLS but may include upper motor neuron (UMN) predominant ALS, defined as only upper motor neuron (UMN) features in at least 2 body regions on examination
  • EMG within 3 months of enrollment with minimal or no evidence of lower motor neuron disease
  • Time from symptom onset more than 18 months
  • No previous allergy to dalfampradine
  • No current or exposure to any therapeutic agent targeting PLS or ALS within 30 days of enrollment
  • Subjects on a stable dose of or have not taken Riluzole for at least thirty days
  • Geographically accessible to the site
  • Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion

For more details about eligibility criteria, please contact Rebecca Zelmanovich:

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

Amyotrophic lateral sclerosis, ALS - resources, ALS, Neurology, Primary Lateral Sclerosis

Principal Investigator

James Wymer, MD, PhD

Department

Neurology

Contact Information

Rebecca.Zelmanovich@neurology.ufl.edu

352-294-5030


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