Use of Dalfampridin in Primary Lateral Sclerosis
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.
- 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:
- 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:
Can be done from home
KeywordsAmyotrophic lateral sclerosis, ALS - resources, ALS, Neurology, Primary Lateral Sclerosis
Principal InvestigatorJames Wymer, MD, PhD
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Studies listed on this site have been approved by a UF Institutional Review Board (IRB), which works to ensure the welfare and rights of research participants as required by federal regulations. Study listings are provided by the UF Clinical and Translational Science Institute in collaboration with UF research teams and the UF IRBs.