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Quick Info
Status
This study has been terminated
Estimated Enrollment
143
Phase
2/ 3
Treatment Type
Drug: Acthar and Placebo
Trial Type
Randomized, parallel assignment
Sponsor
Primary Investigator
Susan VanMeter - Study Director
Contact Information
Locations
Argentina, Other
IADIN, Ciudad Autonoma de Buenos Aires, C1015ABR, Argentina
STAT Research, Ciudad Autonoma de Buenos Aires, C1023AAB, Argentina
DIABAID, Ciudad Autonoma de Buenos Aires, C1061ABD, Argentina
INEBA, Ciudad Autonoma de Buenos Aires, C1192AAW, Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, C1199ABB, Argentina
Hospital Español, Ciudad Autonoma de Buenos Aires, C1209AAB, Argentina
Hospital Británico de Buenos Aires, Ciudad Autonoma de Buenos Aires, C1280AEB, Argentina
ILAIM, Ciudad de Córdoba, X5000BNB, Argentina
Fundación Scherbovsky, Ciudad de Mendoza, CP 5500, Argentina
Instituto de Neurología y Neurorrehabilitación del Litoral (INNeL ), Ciudad De Santa Fe, S3000ASL, Argentina
Canada, Alberta
Edmonton Kaye Clinic, Edmonton, AB, T6G 1Z1, Canada
Canada, Quebec
Recherche Sepmus inc, Greenfield Park, QC, J4V 2J2, Canada
Centre de recherché du Centre Hospitalier de l'Universite de Montreal (CRCHUM), Montréal, QC, H2XOA9, Canada
Montreal Neurological Institute & Hospital, Montréal, QC, H3A 2B4, Canada
Chile, Other
Centro de Trastornos del Movimiento (CETRAM), Santiago, 8380815, Chile
Clinica Dávila, Santiago, 8431657, Chile
Biomedica Research Group AV Salvador 149, oficina 1101, Santiago, 7500710, Chile
Colombia, Other
Centro de Investigaciones Clínicas SAS, Cali, 760036, Colombia
Mexico, Other
Centro Especializado en Investigación Clínica S.C., Boca Del Río, 94290, Mexico
Phylasis Clinicas Research, Mexico City, 54769, Mexico
Hospital Universitario "Dr. José Eleuterio González", Monterrey, 64460, Mexico
SMIQ BRCR Global México, Querétaro City, 76090, Mexico
Clinical Research Institute Saltillo S.A. de C.V., Saltillo, 25020, Mexico
Clinical Research Institute S.C., San Lucas Tepetlacalco, 54055, Mexico
FAICIC Clinical Researc, Veracruz, 91900, Mexico
Peru, Other
Hospital Nivel IV Carlos Alberto Seguin Escobedo, Arequipa, 04001, Peru
Hospital Nacional IV Alberto Sabogal Sologuren, Callao, 07016, Peru
Hospital Almenara, Lima, 15033, Peru
Instituto Neuro Cardiovascular de las Américas, Lima, 15074, Peru
Hospital Nacional Cayetano Heredia, Lima, 15102, Peru
United States, Arizona
Neuromuscular Research Center, Phoenix, AZ, 85028, United States
Mayo Clinic - Arizona, Scottsdale, AZ, 85259, United States
United States, California
University of California San Diego, La Jolla, CA, 92037, United States
Loma Linda University Health System, Department of Neurology, Loma Linda, CA, 92354, United States
Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, United States
University of California Los Angeles, Los Angeles, CA, 90095, United States
University of California Irvine Medical Center, Orange, CA, 92868, United States
California Pacific Medical Center, San Francisco, CA, 94115, United States
University of California San Francisco, San Francisco, CA, 94143, United States
United States, Colorado
Colorado Springs Neurological Associates, Colorado Springs, CO, 80907, United States
United States, District of Columbia
Georgetown University, Washington, DC, 20007, United States
George Washington University, Washington, DC, 20037, United States
United States, Florida
University of Florida - McKnight Brain Institute, Gainesville, FL, 32611, United States
University of South Florida, Tampa, FL, 33612, United States
United States, Georgia
Emory University, Atlanta, GA, 30322, United States
Augusta University, Augusta, GA, 30912, United States
United States, Indiana
Indiana University-Neuroscience Center of Excellence/Goodman Hall, Indianapolis, IN, 46202, United States
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
United States, Kentucky
University of Kentucky Chandler Medical Center, Lexington, KY, 40536, United States
United States, Maryland
John Hopkins Outpatient Center, Baltimore, MD, 21287, United States
United States, Massachusetts
University of Massachusetts Medical School, Worcester, MA, 01655, United States
United States, Michigan
Mercy Health- Saint Mary's, Grand Rapids, MI, 49503, United States
United States, Nebraska
Neurology Associates, Lincoln, NE, 68510, United States
University of Nebraska Medical Center - Physicians Clinical Neurosciences Center, Omaha, NE, 68198, United States
United States, Nevada
Las Vegas Clinic, Las Vegas, NV, 89145, United States
United States, New Jersey
Jersey Shore University Medical Center, Neptune, NJ, 07753, United States
United States, New York
Columbia Presbyterian Hospital, New York, NY, 10032, United States
United States, Oregon
Providence ALS Center, Portland, OR, 97213, United States
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center, Hershey, PA, 17033, United States
Temple University School of Medicine, Philadelphia, PA, 19140, United States
Allegheny General Hospital, Pittsburgh, PA, 15212, United States
United States, Tennessee
Wesley Neurology Clinic, Cordova, TN, 38018, United States
United States, Texas
Austin Neuromuscular Center, Austin, TX, 78756, United States
Texas Neurology, P.A., Dallas, TX, 75214, United States
The Methodist Hospital, Houston, TX, 77030, United States
United States, Vermont
University of Vermont Medical Center, Colchester, VT, 05401, United States
United States, Virginia
VCU Medical Center, Richmond, VA, 23298, United States
United States, Washington
Swedish Neuroscience Institute, Seattle, WA, 98122, United States
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI, 53226, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥ 60%
Months Since Onset
Number of months since first symptoms of ALS.
≤ 2 years
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
no
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
no
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
New results posted
10/15/2020
No significant updates
9/9/2020
Trial terminated
10/18/2019
No significant updates
10/15/2019
Recruitment status updated.
7/23/2019
Description updated
6/5/2019
Locations added
11/23/2018
Locations updated
10/26/2018
Locations updated
8/9/2018
Locations updated
5/4/2018
Locations added
3/26/2018
Locations added
9/27/2017
Description and Location updated
9/21/2017
Location added
8/17/2017
Locations added
8/7/2017
7/11/2017
Recruitment status updated
6/19/2017
No significant updates
5/22/2017
Trial added
3/6/2017

Other Information

Purpose
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.
Eligibility
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
Details
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.
Collaborator(s)
  • Mallinckrodt
Trial Protocol as Published on Clinicaltrials.gov
NCT03068754 (First Published: 2/23/2017)