A Multicenter, 18-week Open Label Safety and Efficacy Trial of Dalfampridine in Primary Lateral Sclerosis
Study 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. 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 Wwalk while on medication, compared with the baseline results while off medication.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Primary Lateral Sclerosis (PLS)Study Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IStudy Chair(s)/Principal Investigator(s):
Dr. Dale J. Lange, Weill Medical College of Cornell University
Clinicaltrials.gov ID (11 digit #):
NCT02868567Neals Affiliated?
NoCoordinating Center Contact Information
Hospital for Special SurgeryMona Shahbazi, NP / .(JavaScript must be enabled to view this email address) / 212-774-2361
Shara Holzberg, MS / .(JavaScript must be enabled to view this email address) / 646-797-8592
New York, New York 10021 United States
Full Study Summary:
Study Sponsor:
Weill Medical College of Cornell UniversityParticipant Duration:
18 weeks