Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
This 8-week randomized, open-label evaluation will examine the acute safety and tolerability
of 4 different dosing regimens of Acthar to inform dose selection for future studies of
Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate
the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help
design future studies.
This study will enroll up to 40 patients and include an optional 28-week open-label
extension period plus a 3-week treatment taper and 1-week follow up period. After completion
of Week 8, patients enrolled in a treatment group that is considered safe and tolerable at
that time have the option to continue into the open-label extension period. A 3-week
treatment taper and a follow-up visit are planned for all patients enrolled in the study,
beginning either at Week 8 or at Week 36 if a patient continues into the optional open-label
extension period.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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