ALS STUDY per ALSTDI -- ALS THERAPY DEVELOPMENT INSTITUTE
Purpose: This 8-week randomized, open-label evaluation will examine the acute safety and tolerability of 4 different dosing regimens of Acthar (corticotropin) 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.
Eligibility: People with possible, probable or definite ALS aged 18-80, both genders accepted, no healthy volunteers
Details: 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.
BUMP If this works in Acthar's favor..., will have a HUGE impact on pps even short-term. Even if it doesn't, the tried and true applications are still working well with plenty of additional indications under R&D.
Is that how you read it, drdonrs? It appears the study is mostly for the safety and tolerability, which should be easy for Acthar.(?) the 2nd(?) goal could be interesting.
but i have not medical education at all. so that's just my guess.