Quick Info
Status
Ongoing, But Not Recruiting
Estimated Enrollment
143
Phase
2/3
Treatment Type
Drug: Acthar and Placebo
Trial Type
Randomized, parallel assignment
Sponsor
Mallinckrodt
Primary Investigator
Susan VanMeter - Study Director
Contact Information
Locations
Neuromuscular Research Center, Phoenix, 85208
Mayo Clinic - Arizona, Scottsdale, 85259
Loma Linda University Health System, Department of, Loma Linda, 92354
University of California San Diego, La Jolla, 92037
Keck School of Medicine, University of Southern Ca, Angeles, 90033
University of California Los Angeles, Los Angeles, 90095
University of California Irvine Medical Center, Orange, 92868
California Pacific Medical Center, San Francisco, 94115
Colorado Springs Neurological Associates, Colorado Springs, 80907
George Washington University, Washington,, 20037
Georgetown University, Washington, 20007
University of South Florida, Tampa, 33612
University of Florida - McKnight Brain Institute, Gainesville, 32611
Emory University, Atlanta, 30322
Augusta University, Augusta, 30912
Indiana University-Neuroscience Center of Excellen, Indianapolis, 46202
University of Kansas Medical Center, Kansas City, 66160
University of Kentucky Chandler Medical Center, Lexington, 40536
University of Massachusetts Medical School, Worcester, 01655
John Hopkins Outpatient Center, Baltimore, 21287
Mercy Health- Saint Mary's, Grand Rapids, 49503
Neurology Associates, Lincoln, 68510
University of Nebraska Medical Center - Physicians, Omaha, 68198
Las Vegas Clinic, Las Vegas, 89145
Columbia Presbyterian Hospital, New York, 10032
Providence ALS Center, Portland, 97213
Penn State Health Milton S. Hershey Medical Center, Hershey, 17033
Temple University School of Medicine, Philadelphia, 19140
Allegheny General Hospital, Pittsburgh, 15212
Wesley Neurology Clinic, Cordova, 38018
Texas Neurology, P.A., Dallas, 75214
Austin Neuromuscular Center, Austin, 78756
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, 53226
The Methodist Hospital, Houston, 77030
VCU Medical Center, Richmond, 23298
Swedish Neuroscience Institute, Seattle, 98122
University of California San Francisco, San Francisco, 94143
Centro de Investigaciones Clínicas SAS, Cali, 760036
Jersey Shore University Medical Center, Neptune, 07753
Edmonton Kaye Clinic, Edmonton, T6G 1Z1
Montreal Neurological Institute & Hospital, Montréal, H3A 2B4
Recherche Sepmus inc, Greenfield Park, J4V 2J2
Centre de recherché Centre Hospitalier de l'Universite de Montreal , Montreal, H2XOA9
Centro de Trastornos del Movimiento (CETRAM), Santiago, Metropolitana
Biomedica Research Group AV Salvador 149, oficina 1101, Santiago, 7500710
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
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 and 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
18-75 years, all genders, not accepting healthy volunteers
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)
    -
News Articles and Summaries
ALS Forum
-
Trial Protocol as Published on Clinicaltrials.gov
NCT03068754 (First Published: 2/23/2017)
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