Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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: * 2 will get the study drug * 1 will get a look-alike with no drug in it (placebo) 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.

Key facts

Study ID

NCT03068754

Run by

Mallinckrodt

People needed

143

Starts

2017-06-22

Expected to finish

2019-11-25

Last updated by the study team

2020-10-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is 18-75 years of age at Screening
• Has ALS symptom onset within 2 years prior to Screening
• Has forced vital capacity (FVC) no higher than 60% at screening
• If taking riluzole, is on a stable dose for 4 weeks before Screening

You may not qualify if…

• Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
• Has used any medication within a time period not allowed per protocol
• Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
• Used edaravone less than 1 week before Screening
• Received any stem cell replacement therapy
• Used steroids within a time period not allowed per protocol

Where it is running

• Mayo Clinic - Arizona — Scottsdale, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• Loma Linda University Health System, Department of Neurology — Loma Linda, California, United States
• Keck School of Medicine, University of Southern California — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Florida - McKnight Brain Institute — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Indiana University-Neuroscience Center of Excellence/Goodman Hall — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• John Hopkins Outpatient Center — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Mercy Health- Saint Mary's — Grand Rapids, Michigan, United States
• Neurology Associates — Lincoln, Nebraska, United States
• University of Nebraska Medical Center - Physicians Clinical Neurosciences Center — Omaha, Nebraska, United States
• Las Vegas Clinic — Las Vegas, Nevada, United States
• Neuromuscular Research Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.