Study 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.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Acthar, Placebo
Placebo:
Yes
Phase:
Phase 2/Phase 3
Study Chair(s)/Principal Investigator(s):
Clinical Team Leader, Mallinckrodt
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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.
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.
Study Sponsor:
Mallinckrodt
Estimated Enrollment:
143
Estimated Study Start Date:
06 / 22 / 2017
Estimated Study Completion Date:
11 / 25 / 2019
Posting Last Modified Date:
10 / 14 / 2020
Date Study Added to neals.org:
03 / 03 / 2017
Minimum Age:
18 Years
Maximum Age:
75 Years
Can participants use Riluzole?
Yes
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
Neuromuscular Research Center
Phoenix, Arizona
85028
United States
Mayo Clinic - Arizona
Scottsdale, Arizona
85259
United States
University of California San Diego
La Jolla, California
92037
United States
Loma Linda University Health System, Department of Neurology
Loma Linda, California
92354
United States
Keck School of Medicine, University of Southern California
Los Angeles, California
90033
United States
University of California Los Angeles
Los Angeles, California
90095
United States
University of California Irvine Medical Center
Orange, California
92868
United States
California Pacific Medical Center
San Francisco, California
94115
United States
University of California San Francisco
San Francisco, California
94143
United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado
80907
United States
Georgetown University
Washington, District of Columbia
20007
United States
George Washington University
Washington, District of Columbia
20037
United States
University of Florida - McKnight Brain Institute
Gainesville, Florida
32611
United States
University of South Florida
Tampa, Florida
33612
United States
Emory University
Atlanta, Georgia
30322
United States
Augusta University
Augusta, Georgia
30912
United States
Indiana University-Neuroscience Center of Excellence/Goodman Hall
Indianapolis, Indiana
46202
United States
University of Kansas Medical Center
Kansas City, Kansas
66160
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky
40536
United States
John Hopkins Outpatient Center
Baltimore, Maryland
21287
United States
University of Massachusetts Medical School
Worcester, Massachusetts
01655
United States
Mercy Health- Saint Mary's
Grand Rapids, Michigan
49503
United States
Neurology Associates
Lincoln, Nebraska
68510
United States
University of Nebraska Medical Center - Physicians Clinical Neurosciences Center
Omaha, Nebraska
68198
United States
Las Vegas Clinic
Las Vegas, Nevada
89145
United States
Jersey Shore University Medical Center
Neptune, New Jersey
07753
United States
Columbia Presbyterian Hospital
New York, New York
10032
United States
Providence ALS Center
Portland, Oregon
97213
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania
15212
United States
Temple University School of Medicine
Philadelphia, Pennsylvania
19140
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Wesley Neurology Clinic
Cordova, Tennessee
38018
United States
Austin Neuromuscular Center
Austin, Texas
78756
United States
Texas Neurology, P.A.
Dallas, Texas
75214
United States
The Methodist Hospital
Houston, Texas
77030
United States
University of Vermont Medical Center
Colchester, Vermont
05401
United States
VCU Medical Center
Richmond, Virginia
23298
United States
Swedish Neuroscience Institute
Seattle, Washington
98122
United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin
53226
United States
IADIN
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1015ABR
Argentina
STAT Research
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1023AAB
Argentina
DIABAID
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1061ABD
Argentina
INEBA
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1192AAW
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1199ABB
Argentina
Hospital Español
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1209AAB
Argentina
Hospital Británico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires
C1280AEB
Argentina
ILAIM
Ciudad de Córdoba, Córdoba
X5000BNB
Argentina
Fundación Scherbovsky
Ciudad de Mendoza, Mendoza
CP 5500
Argentina
Instituto de Neurología y Neurorrehabilitación del Litoral (INNeL )
Ciudad De Santa Fe, Santa Fe
S3000ASL
Argentina
Edmonton Kaye Clinic
Edmonton, Alberta
T6G 1Z1
Canada
Recherche Sepmus inc
Greenfield Park, Quebec
J4V 2J2
Canada
Centre de recherché du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montréal, Quebec
H2XOA9
Canada
Montreal Neurological Institute & Hospital
Montréal, Quebec
H3A 2B4
Canada
Biomedica Research Group AV Salvador 149, oficina 1101
Santiago 7500710
Chile
Clinica Dávila
Santiago, Región Metropolitana
8431657
Chile
Centro de Trastornos del Movimiento (CETRAM)
Santiago, Región Metropolitana
8380815
Chile
Centro de Investigaciones Clínicas SAS
Cali 760036
Colombia
Clinical Research Institute Saltillo S.A. de C.V.
Saltillo, Coahuila
25020
Mexico
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo Leon
64460
Mexico
SMIQ BRCR Global México
Querétaro City, Querétaro
76090
Mexico
Clinical Research Institute S.C.
San Lucas Tepetlacalco, Tlalnepantla De Baz
54055
Mexico
Centro Especializado en Investigación Clínica S.C.
Boca Del Río, Veracruz
94290
Mexico
Phylasis Clinicas Research
Mexico City 54769
Mexico
FAICIC Clinical Researc
Veracruz 91900
Mexico
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