Back to resultsStudy of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Acthar
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS
Eligibility Criteria
Inclusion Criteria:
- Is 18-75 years of age at Screening
- Has ALS symptom onset within 2 years prior to Screening
- Has forced vital capacity (FVC) no higher than 60% at screening
- If taking riluzole, is on a stable dose for 4 weeks before Screening
Exclusion Criteria:
- Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
- Has used any medication within a time period not allowed per protocol
- Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
- Used edaravone less than 1 week before Screening
- Received any stem cell replacement therapy
- Used steroids within a time period not allowed per protocol
Sites / Locations
- Neuromuscular Research Center
- Mayo Clinic - Arizona
- University of California San Diego
- Loma Linda University Health System, Department of Neurology
- Keck School of Medicine, University of Southern California
- University of California Los Angeles
- University of California Irvine Medical Center
- California Pacific Medical Center
- University of California San Francisco
- Colorado Springs Neurological Associates
- Georgetown University
- George Washington University
- University of Florida - McKnight Brain Institute
- University of South Florida
- Emory University
- Augusta University
- Indiana University-Neuroscience Center of Excellence/Goodman Hall
- University of Kansas Medical Center
- University of Kentucky Chandler Medical Center
- John Hopkins Outpatient Center
- University of Massachusetts Medical School
- Mercy Health- Saint Mary's
- Neurology Associates
- University of Nebraska Medical Center - Physicians Clinical Neurosciences Center
- Las Vegas Clinic
- Jersey Shore University Medical Center
- Columbia Presbyterian Hospital
- Providence ALS Center
- Penn State Health Milton S. Hershey Medical Center
- Temple University School of Medicine
- Allegheny General Hospital
- Wesley Neurology Clinic
- Austin Neuromuscular Center
- Texas Neurology, P.A.
- The Methodist Hospital
- University of Vermont Medical Center
- VCU Medical Center
- Swedish Neuroscience Institute
- Medical College of Wisconsin/Froedtert Hospital
- IADIN
- STAT Research
- DIABAID
- INEBA
- Hospital Italiano de Buenos Aires
- Hospital Español
- Hospital Británico de Buenos Aires
- ILAIM
- Fundación Scherbovsky
- Instituto de Neurología y Neurorrehabilitación del Litoral (INNeL )
- Edmonton Kaye Clinic
- Recherche Sepmus inc
- Centre de recherché du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
- Montreal Neurological Institute & Hospital
- Centro de Trastornos del Movimiento (CETRAM)
- Clinica Dávila
- Biomedica Research Group AV Salvador 149, oficina 1101
- Centro de Investigaciones Clínicas SAS
- Clinical Research Institute Saltillo S.A. de C.V.
- Hospital Universitario "Dr. José Eleuterio González"
- SMIQ BRCR Global México
- Clinical Research Institute S.C.
- Centro Especializado en Investigación Clínica S.C.
- Phylasis Clinicas Research
- FAICIC Clinical Researc
- Hospital Nivel IV Carlos Alberto Seguin Escobedo
- Hospital Nacional IV Alberto Sabogal Sologuren
- Hospital Almenara
- Instituto Neuro Cardiovascular de las Américas
- Hospital Nacional Cayetano Heredia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Arm A: Treatment Period Acthar
Arm B: Treatment Period Placebo
Arm C: Extension Period Acthar-Acthar
Arm D: Extension Period Placebo-Acthar
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival.
ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory)
A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Number of Participants Experiencing an Adverse Event During the Treatment Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study Clinically significant changes in safety measures are recorded as adverse events.
Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study (estimated about 1 year for participants leaving after the treatment period, and two years for participants who participate also in the open label extension). Clinically significant changes in safety measures are recorded as adverse events.
Secondary Outcome Measures
Treatment Period: Spirometry (%)
Spirometry (meaning the measuring of breath) is the most common of the lung function tests. It measures how much air can be inhaled [Forced Vital Capacity (FVC)] and exhaled [(Forced Expiratory Volume in one second (FEV1)].
Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible score of 48. Higher scores represent better function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03068754
Brief Title
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
As recommended by the study's independent Data and Safety Monitoring Board (DSMB)
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Treatment Period Acthar
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: Treatment Period Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Arm C: Extension Period Acthar-Acthar
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm D: Extension Period Placebo-Acthar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acthar
Other Intervention Name(s)
Trade name: Acthar® Gel, Generic name: repository corticotropin injection
Intervention Description
Repository corticotropin for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo, Reference Product
Intervention Description
Matching placebo for subcutaneous injection
Primary Outcome Measure Information:
Title
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Description
The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival.
ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory)
A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Time Frame
Baseline, Week 36
Title
Number of Participants Experiencing an Adverse Event During the Treatment Period
Description
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study Clinically significant changes in safety measures are recorded as adverse events.
Time Frame
by the end of the treatment period (within 36 Weeks)
Title
Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period
Description
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study (estimated about 1 year for participants leaving after the treatment period, and two years for participants who participate also in the open label extension). Clinically significant changes in safety measures are recorded as adverse events.
Time Frame
by the time of database lock (within 84 weeks)
Secondary Outcome Measure Information:
Title
Treatment Period: Spirometry (%)
Description
Spirometry (meaning the measuring of breath) is the most common of the lung function tests. It measures how much air can be inhaled [Forced Vital Capacity (FVC)] and exhaled [(Forced Expiratory Volume in one second (FEV1)].
Time Frame
Baseline, Week 36
Title
Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R
Description
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function.
Time Frame
Baseline, Week 36
Title
Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R
Description
The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).
The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible score of 48. Higher scores represent better function.
Time Frame
Baseline, Week 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is 18-75 years of age at Screening
Has ALS symptom onset within 2 years prior to Screening
Has forced vital capacity (FVC) no higher than 60% at screening
If taking riluzole, is on a stable dose for 4 weeks before Screening
Exclusion Criteria:
Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
Has used any medication within a time period not allowed per protocol
Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
Used edaravone less than 1 week before Screening
Received any stem cell replacement therapy
Used steroids within a time period not allowed per protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Mayo Clinic - Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Loma Linda University Health System, Department of Neurology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Keck School of Medicine, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Florida - McKnight Brain Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Indiana University-Neuroscience Center of Excellence/Goodman Hall
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
John Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mercy Health- Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Neurology Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
University of Nebraska Medical Center - Physicians Clinical Neurosciences Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Las Vegas Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Providence ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Wesley Neurology Clinic
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
IADIN
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABR
Country
Argentina
Facility Name
STAT Research
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
DIABAID
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1061ABD
Country
Argentina
Facility Name
INEBA
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1192AAW
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Español
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1209AAB
Country
Argentina
Facility Name
Hospital Británico de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
ILAIM
City
Ciudad de Córdoba
State/Province
Córdoba
ZIP/Postal Code
X5000BNB
Country
Argentina
Facility Name
Fundación Scherbovsky
City
Ciudad de Mendoza
State/Province
Mendoza
ZIP/Postal Code
CP 5500
Country
Argentina
Facility Name
Instituto de Neurología y Neurorrehabilitación del Litoral (INNeL )
City
Ciudad De Santa Fe
State/Province
Santa Fe
ZIP/Postal Code
S3000ASL
Country
Argentina
Facility Name
Edmonton Kaye Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Recherche Sepmus inc
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Centre de recherché du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2XOA9
Country
Canada
Facility Name
Montreal Neurological Institute & Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Centro de Trastornos del Movimiento (CETRAM)
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8380815
Country
Chile
Facility Name
Clinica Dávila
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8431657
Country
Chile
Facility Name
Biomedica Research Group AV Salvador 149, oficina 1101
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Centro de Investigaciones Clínicas SAS
City
Cali
ZIP/Postal Code
760036
Country
Colombia
Facility Name
Clinical Research Institute Saltillo S.A. de C.V.
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Hospital Universitario "Dr. José Eleuterio González"
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
SMIQ BRCR Global México
City
Querétaro City
State/Province
Querétaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Clinical Research Institute S.C.
City
San Lucas Tepetlacalco
State/Province
Tlalnepantla De Baz
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Centro Especializado en Investigación Clínica S.C.
City
Boca Del Río
State/Province
Veracruz
ZIP/Postal Code
94290
Country
Mexico
Facility Name
Phylasis Clinicas Research
City
Mexico City
ZIP/Postal Code
54769
Country
Mexico
Facility Name
FAICIC Clinical Researc
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Hospital Nivel IV Carlos Alberto Seguin Escobedo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital Nacional IV Alberto Sabogal Sologuren
City
Callao
ZIP/Postal Code
07016
Country
Peru
Facility Name
Hospital Almenara
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Instituto Neuro Cardiovascular de las Américas
City
Lima
ZIP/Postal Code
15074
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
15102
Country
Peru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
We'll reach out to this number within 24 hrs