Actively Recruiting
HEALEY ALS Platform Trial - Master Protocol
Led by Merit E. Cudkowicz, MD · Updated on 2026-05-14
1500
Participants Needed
78
Research Sites
424 weeks
Total Duration
On this page
Sponsors
M
Merit E. Cudkowicz, MD
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
CONDITIONS
Official Title
HEALEY ALS Platform Trial - Master Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with sporadic or familial ALS as clinically possible, probable, lab-supported probable, or definite ALS by revised El Escorial criteria
- Age 18 years or older
- Able to provide informed consent and follow study procedures
- Onset of weakness from ALS within 24 months before the screening visit
- Vital capacity of 50% or higher of predicted capacity measured by Slow Vital Capacity or Forced Vital Capacity
- Either not taking riluzole or on a stable riluzole dose for at least 30 days before screening
- Either not taking edaravone or completed at least one cycle of edaravone before screening
- Able to swallow pills and liquids at screening and expected to do so during the study
- Geographically accessible to the study site
You will not qualify if you...
- Unstable medical conditions or significant lab abnormalities such as liver or kidney dysfunction
- Unstable psychiatric disease, cognitive impairment, dementia, or substance abuse affecting consent ability
- Active cancer or history of cancer except certain skin or curatively treated cancers with no recurrence for 3 years
- Use of investigational ALS treatments within 5 half-lives or 30 days before screening
- Any prior exposure to investigational gene therapies for ALS
- For females, breastfeeding, pregnant, planning pregnancy, or unwilling to use contraception during and 3 months after the trial
- For males with reproductive capacity, unwilling to use contraception during and 3 months after the trial
- Any condition increasing risk or preventing full study compliance as judged by the investigator
- Unresolved disqualifying conditions or insufficient wash-out period if re-screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 78 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Loma Linda University Health
Loma Linda, California, United States, 92354
Active, Not Recruiting
5
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Active, Not Recruiting
6
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
7
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
8
University of California, Irvine
Orange, California, United States, 92868
Active, Not Recruiting
9
Forbes Norris MDA/ALS Research Center, California Pacific Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
10
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
11
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
12
Hospital for Special Care
New Britain, Connecticut, United States, 06053
Actively Recruiting
13
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
14
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
15
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
16
Nova Southeastern University
Davie, Florida, United States, 33024
Actively Recruiting
17
University of Florida
Gainesville, Florida, United States, 32610
Active, Not Recruiting
18
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
19
University of Miami
Miami, Florida, United States, 33136
Active, Not Recruiting
20
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
21
Augusta University
Augusta, Georgia, United States, 30912
Active, Not Recruiting
22
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83704
Active, Not Recruiting
23
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
24
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
25
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
26
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
27
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
Actively Recruiting
28
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
29
Ochsner Health System
New Orleans, Louisiana, United States, 70115
Active, Not Recruiting
30
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Active, Not Recruiting
31
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
32
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
33
University of Massachusetts Medical School
North Worcester, Massachusetts, United States, 01655
Actively Recruiting
34
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
35
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
36
Spectrum Health/Corewell Health
Grand Rapids, Michigan, United States, 49525
Actively Recruiting
37
Essentia Health
Duluth, Minnesota, United States, 55805
Actively Recruiting
38
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
39
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55902
Actively Recruiting
40
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Actively Recruiting
41
Saint Louis University
St Louis, Missouri, United States, 63104
Actively Recruiting
42
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
43
Neurology Associates, P.C./Somnos Clinical Research
Lincoln, Nebraska, United States, 68506
Active, Not Recruiting
44
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
45
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
46
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Active, Not Recruiting
47
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
48
Mount Sinai
New York, New York, United States, 10003
Actively Recruiting
49
Columbia University
New York, New York, United States, 10032
Actively Recruiting
50
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
51
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
52
SUNY Upstate
Syracuse, New York, United States, 13202
Actively Recruiting
53
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Active, Not Recruiting
54
Atrium Health
Charlotte, North Carolina, United States, 28207
Actively Recruiting
55
Duke University
Durham, North Carolina, United States, 27702
Actively Recruiting
56
Wake Forest Health Science
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
57
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
58
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
59
The Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
60
OhioHealth Research Institute
Westerville, Ohio, United States, 43082
Actively Recruiting
61
Providence Brain and Spine Institute ALS Center
Portland, Oregon, United States, 97213
Active, Not Recruiting
62
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
63
Penn State Hershey
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
64
Jefferson Weinberg ALS Center, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
65
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
66
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
67
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
68
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
69
Austin Neuromuscular Clinic
Austin, Texas, United States, 78759
Actively Recruiting
70
Texas Neurology
Dallas, Texas, United States, 75214
Actively Recruiting
71
Houston Methodist
Houston, Texas, United States, 77030
Active, Not Recruiting
72
UTHSCSA
San Antonio, Texas, United States, 78229
Active, Not Recruiting
73
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
74
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
75
Virginia Commonwealth University
Henrico, Virginia, United States, 23233
Active, Not Recruiting
76
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
77
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
78
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
H
HEALEY Center for ALS at Massachusetts General Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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