At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of clinically definite, clinically probable-laboratory supported, clinically probable, or clinically possible ALS per revised El Escorial criteria
- ✓Time since ALS symptom onset ≤3 years
- ✓Upright slow vital capacity ≥60% of predicted
- ✓If on riluzole and/or Nuedexta, must be on stable regimen for ≥30 days prior to screening
- ✕Any medical condition associated with motor neuron dysfunction that could confound or obscure ALS diagnosis
- ✕Tracheostomy, diaphragm pacing, or any assisted ventilation (except supplemental oxygen alone) for ALS-related respiratory dysfunction
- ✕Recorded diagnosis or evidence of major psychiatric disorder
- ✕Clinically evident cognitive and/or behavioral impairment that would impair ability to comply with study procedures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
In Brief
A Phase 2 clinical trial evaluating Repository corticotropin injection for Amyotrophic Lateral Sclerosis. Completed, enrolled 43 participants across 17 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks