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

NCT03068754 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-10-14

Study results available
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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.

Conditions

Interventions

DRUG

Acthar

Repository corticotropin for subcutaneous injection

DRUG

Placebo

Matching placebo for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-11-25
Completion
2019-11-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Colombia
  • Mexico
  • Peru

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068754 on ClinicalTrials.gov