Overview

Use of Dalfampridine in Primary Lateral Sclerosis

Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
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. At the initial screening evaluation, a baseline T25FW will be obtained. This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of this measure was shown in MS studies when compared to the MSWS-12 (12 item walking scale) and CGI (clinical global impression) scales (35-37). A consistent responder will be defined as improvement in 3 of 4 Timed 25Foot Walk while on medication, compared with the baseline results while off medication.
Phase:
Phase 1
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborator:
Hospital for Special Surgery, New York
Treatments:
4-Aminopyridine