NCT02868567

Use of Dalfampridine in Primary Lateral Sclerosis

A Multicenter, 18-week Open Label Safety and Efficacy Trial of Dalfampridine in Primary Lateral Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Motor Neuron Disease, Upper

Interventions

Type	Name	Description
DRUG	dalfampridine	Pill open label

Timeline

• Start date: 2016-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2016-08-16
• Last updated: 2025-09-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study