A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Study Purpose:
This is a multicenter, multiple dose study to examine the effect of H.P. Acthar® (Acthar) on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS).
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Susan VanMeter, Mallinckrodt
Clinicaltrials.gov ID (11 digit #):
NCT03068754Neals Affiliated?
NoCoordinating Center Contact Information
Michael Zhang / .(JavaScript must be enabled to view this email address) / 800-556-3314
.(JavaScript must be enabled to view this email address)
Full Study Summary:
This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS). Approximately 195 subjects will be enrolled.
Following a screening period of up to 28 days, subjects with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units ) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3 week taper.