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Study of Acthar® Gel (Acthar...

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

Last Updated: 2020-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2019-11-25

Brief Summary

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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.

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Detailed Description

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This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.

Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units \[U\]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.

Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to treatment group randomly (like flipping a coin). They will have a 2 out of 3 chance of receiving the study drug, and a 1 out of 3 chance of receiving placebo during the treatment period. All participants who continue into the extension period receive Acthar.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The Treatment Period is defined as Randomized (2:1, Arm A: Arm B), Double-blind (with care provider and outcomes assessor also blinded).

The Extension Period has no masking, because all who participate receive open label study drug.

Study Groups

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Arm A: Treatment Period Acthar

Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar), daily for up to 36 weeks.

Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39.

Group Type EXPERIMENTAL

Acthar

Intervention Type DRUG

Repository corticotropin for subcutaneous injection

Arm B: Treatment Period Placebo

Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (Matching Placebo), daily for up to 36 weeks.

Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo for subcutaneous injection

Arm C: Extension Period Acthar-Acthar

Participants who receive Acthar during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.

Group Type EXPERIMENTAL

Acthar

Intervention Type DRUG

Repository corticotropin for subcutaneous injection

Arm D: Extension Period Placebo-Acthar

Participants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.

Group Type EXPERIMENTAL

Acthar

Intervention Type DRUG

Repository corticotropin for subcutaneous injection

Placebo

Intervention Type DRUG

Matching placebo for subcutaneous injection

Interventions

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Acthar

Repository corticotropin for subcutaneous injection

Intervention Type DRUG

Placebo

Matching placebo for subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Trade name: Acthar® Gel Generic name: repository corticotropin injection Matching Placebo Reference Product

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Team Leader

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

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Neuromuscular Research Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic - Arizona

Scottsdale, Arizona, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

Loma Linda University Health System, Department of Neurology

Loma Linda, California, United States

Site Status

Keck School of Medicine, University of Southern California

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

University of California Irvine Medical Center

Orange, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

University of Florida - McKnight Brain Institute

Gainesville, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

Indiana University-Neuroscience Center of Excellence/Goodman Hall

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

John Hopkins Outpatient Center

Baltimore, Maryland, United States

Site Status

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Mercy Health- Saint Mary's

Grand Rapids, Michigan, United States

Site Status

Neurology Associates

Lincoln, Nebraska, United States

Site Status

University of Nebraska Medical Center - Physicians Clinical Neurosciences Center

Omaha, Nebraska, United States

Site Status

Las Vegas Clinic

Las Vegas, Nevada, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Columbia Presbyterian Hospital

New York, New York, United States

Site Status

Providence ALS Center

Portland, Oregon, United States

Site Status

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Wesley Neurology Clinic

Cordova, Tennessee, United States

Site Status

Austin Neuromuscular Center

Austin, Texas, United States

Site Status

Texas Neurology, P.A.

Dallas, Texas, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

University of Vermont Medical Center

Colchester, Vermont, United States

Site Status

VCU Medical Center

Richmond, Virginia, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status