Clinical Trial

Use of Dalfampridine in Primary Lateral Sclerosis

Active, Not Recruiting Phase 1
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Record status
This record was last updated September 11, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2016-08-14; most recent amendment 2025-09-04.
Status change: Recruiting → Active, Not Recruiting 2022-03-29
Trial Details
NCT Number NCT02868567
Lead Sponsor Hospital for Special Surgery, New York
Conditions Motor Neuron Disease, Upper
Enrollment 35 participants
Start Date 2016-03
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-11