Last updated on November 2018

A Study to Assess the Efficacy and Safety of H.P. Acthar Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis


Brief description of study

This is a multicenter, multiple dose study to examine the effect of H.P. Acthar (Acthar) on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS).

Detailed Study Description

This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS). Approximately 213 subjects will be enrolled.

Following a screening period of up to 28 days, subjects 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.

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

Clinical Study Identifier: NCT03068754

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Lisa Fitzgerald, BS, CCRA

Neuromuscular Research Center
Phoenix, AZ United States
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Lisa Fitzgerald, BS, CCRA

Loma Linda University Health System, Department of Neurology
Loma Linda, CA United States
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Lisa Fitzgerald, BS, CCRA

Colorado Springs Neurological Associates
Colorado Springs, CO United States
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Lisa Fitzgerald, BS, CCRA

University of South Florida
Tampa, FL United States
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Lisa Fitzgerald, BS, CCRA

Indiana University-Neuroscience Center of Excellence/Goodman Hall
Indianapolis, IN United States
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Lisa Fitzgerald, BS, CCRA

University of Kansas Medical Center
Kansas City, KS United States
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Lisa Fitzgerald, BS, CCRA

John Hopkins Outpatient Center
Baltimore, MD United States
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Lisa Fitzgerald, BS, CCRA

Wesley Neurology Clinic
Cordova, TN United States
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Lisa Fitzgerald, BS, CCRA

Austin Neuromuscular Center
Austin, TX United States
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Lisa Fitzgerald, BS, CCRA

Texas Neurology, P.A.
Dallas, TX United States
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Lisa Fitzgerald, BS, CCRA

Medical College of Wisconsin/Froedtert Hospital
Milwaukee, WI United States
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Lisa Fitzgerald, BS, CCRA

Mayo Clinic - Arizona
Scottsdale, AZ United States
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Lisa Fitzgerald, BS, CCRA

University of California San Diego
La Jolla, CA United States
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Lisa Fitzgerald, BS, CCRA

Keck School of Medicine, University of Southern California
Los Angeles, CA United States
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Lisa Fitzgerald, BS, CCRA

University of California Los Angeles
Los Angeles, CA United States
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Lisa Fitzgerald, BS, CCRA

University of California Irvine Medical Center
Orange, CA United States
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Lisa Fitzgerald, BS, CCRA

California Pacific Medical Center
San Francisco, CA United States
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Lisa Fitzgerald, BS, CCRA

Georgetown University
Washington, WA United States
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Lisa Fitzgerald, BS, CCRA

George Washington University
Washington, WA United States
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Lisa Fitzgerald, BS, CCRA

University of Florida - McKnight Brain Institute
Gainesville, FL United States
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Lisa Fitzgerald, BS, CCRA

Emory University
Atlanta, GA United States
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Lisa Fitzgerald, BS, CCRA

Augusta University
Augusta, GA United States
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Lisa Fitzgerald, BS, CCRA

University of Kentucky Chandler Medical Center
Lexington, KY United States
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Lisa Fitzgerald, BS, CCRA

University of Massachusetts Medical School
Worcester, MA United States
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Lisa Fitzgerald, BS, CCRA

Mercy Health- Saint Mary's
Grand Rapids, MI United States
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Lisa Fitzgerald, BS, CCRA

Neurology Associates
Lincoln, NE United States
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Lisa Fitzgerald, BS, CCRA

University of Nebraska Medical Center - Physicians Clinical Neurosciences Center
Omaha, NE United States
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Lisa Fitzgerald, BS, CCRA

Las Vegas Clinic
Las Vegas, NV United States
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Lisa Fitzgerald, BS, CCRA

Columbia Presbyterian Hospital
New York, NY United States
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Lisa Fitzgerald, BS, CCRA

Providence ALS Center
Portland, OR United States
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Lisa Fitzgerald, BS, CCRA

Penn State Health Milton S. Hershey Medical Center
Hershey, PA United States
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Lisa Fitzgerald, BS, CCRA

Temple University School of Medicine
Philadelphia, PA United States
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Lisa Fitzgerald, BS, CCRA

Allegheny General Hospital
Pittsburgh, PA United States
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Lisa Fitzgerald, BS, CCRA

The Methodist Hospital
Houston, TX United States
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Lisa Fitzgerald, BS, CCRA

VCU Medical Center
Richmond, VA United States
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Lisa Fitzgerald, BS, CCRA

Swedish Neuroscience Institute
Seattle, WA United States
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Lisa Fitzgerald, BS, CCRA

University of California San Francisco
San Francisco, CA United States
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Lisa Fitzgerald, BS, CCRA

Centro de Investigaciones Cl nicas SAS
Cali, Colombia
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Lisa Fitzgerald, BS, CCRA

University of Vermont Medical Center
Colchester, VT United States
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Lisa Fitzgerald, BS, CCRA

Jersey Shore University Medical Center
Neptune, NJ United States
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Lisa Fitzgerald, BS, CCRA

Edmonton Kaye Clinic
Edmonton, AB Canada
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Lisa Fitzgerald, BS, CCRA

Recherche Sepmus inc
Greenfield Park, QC Canada
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Lisa Fitzgerald, BS, CCRA

Centro de Trastornos del Movimiento (CETRAM)
Santiago, Chile
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Lisa Fitzgerald, BS, CCRA

Centre de recherch du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montréal, QC Canada
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Lisa Fitzgerald, BS, CCRA

Montreal Neurological Institute & Hospital
Montréal, QC Canada
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Lisa Fitzgerald, BS, CCRA

Biomedica Research Group AV Salvador 149, oficina 1101
Santiago, Chile
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Recruitment Status: Open


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