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

• Status: Terminated
• Trial end date: 2019-11-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

1. Is 18-75 years of age at Screening

2. Has ALS symptom onset within 2 years prior to Screening

3. Has forced vital capacity (FVC) no higher than 60% at screening

4. If taking riluzole, is on a stable dose for 4 weeks before Screening

Exclusion Criteria:

1. Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type

2. Has used any medication within a time period not allowed per protocol

3. Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection

4. Used edaravone less than 1 week before Screening

5. Received any stem cell replacement therapy

6. Used steroids within a time period not allowed per protocol