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
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
About 213 people with ALS will participate in this study. There will be locations in North and South America.
During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3:
During the second part, everyone will get the study drug.
Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.
This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.
Following a screening period of up to 28 days, participants 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 [U]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.
Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.
Inclusion Criteria:
Exclusion Criteria:
Loma Linda, California 92354, United States
Los Angeles, California 90033, United States
Indianapolis, Indiana 46202, United States
Omaha, Nebraska 68198, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1015ABR, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1023AAB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1061ABD, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1192AAW, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1209AAB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1280AEB, Argentina
Santa Fe, Santa Fe Province S3000ASL, Argentina
Montreal, Quebec H2XOA9, Canada