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Quick Info
Enrolling by invitation
Trial Type
Treatment Type
Drug Trials
Start Date
Contact Information
United States, Arizona
Barrow Neurological Institute, AZ, United States
Contact: Whitney Dailey
United States, California
Cedars-Sinai Medical Center, CA, United States
Contact: Sophia Mostowy
Forbes Norris MDA/ALS Research Center, California Pacific Medical Center, CA, United States
Contact: Teji Dulai
Kaiser Permanente, Los Angeles Medical Center, CA, United States
Contact: Mary H. Berganza
Loma Linda University Health, CA, United States
Contact: David Borg
University of California, Irvine, CA, United States
Contact: Pola Gaid
University of California, San Francisco, CA, United States
Contact: Reshma Kolala
University of Southern California, CA, United States
Contact: Salma Akhter
United States, Colorado
University of Colorado Anschutz, CO, United States
Contact: Recruitment Coordinator
United States, Connecticut
Hospital for Special Care, CT, United States
Contact: Natalie Cartwright
United States, District of Columbia
Georgetown University Pasquerilla Health Center, DC, United States
Contact: Gabby Law
George Washington University, DC, United States
Contact: Grace Johnson
United States, Florida
Mayo Clinic Florida, FL, United States
Contact: Jany Paulett
Nova Southeastern University, FL, United States
Contact: Donovan Mott
Phil Smith Neuroscience Institute, Holy Cross Hospital, FL, United States
Contact: Ashley Stepler
University of Florida Gainesville, FL, United States
Contact: Jennifer Steshyn
University of Miami, FL, United States
Contact: Jessica Hernandez
University of South Florida College of Medicine, FL, United States
Contact: Jessica Shaw
United States, Georgia
Augusta University, GA, United States
Contact: Brandy Quarles
Emory University, GA, United States
Contact: N/A
United States, Idaho
Saint Alphonsus Regional Medical Center, ID, United States
Contact: Research Coordinator
United States, Illinois
Northwestern University, IL, United States
Contact: Emma Schmidt
University of Chicago, IL, United States
Contact: Deekshitha Turaka
United States, Iowa
University of Iowa Hospitals and Clinics, IA, United States
Contact: Emily Anderson
United States, Kansas
University of Kansas Medical Center, KS, United States
Contact: Katheryn Jennens
United States, Kentucky
University of Kentucky, KY, United States
Contact: Sura Al Hilfi
United States, Louisiana
Ochsner Health Systems, LA, United States
Contact: Lisa Edmond
United States, Maryland
Johns Hopkins University, MD, United States
Contact: Kristen Riley
University of Maryland, MD, United States
Contact: Vikram Nambiar
United States, Massachusetts
Beth Israel Deaconess Medical Center, MA, United States
Contact: Teresa  Capella
Massachusetts General Hospital, MA, United States
Contact: Suhina Patel
University of Massachusetts Medical School, Worcester, MA, United States
Contact: Catherine Douthwright
Healey Center for ALS at Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Michigan
Henry Ford Health System, MI, United States
Contact: Beverley Duthie
University of Michigan, MI, United States
Contact: Jayna Duell
Spectrum Health, MI, United States
Contact: Sehrish Khan
United States, Minnesota
Essentia Health, MN, United States
Contact: Brent Gavin
Mayo Clinic Rochester, MN, United States
Contact: Brenda Nelson
University of Minnesota Twin Cities ALS Research Consortium, MN, United States
Contact: Valerie Ferment
United States, Missouri
University of Missouri Health Care, MO, United States
Contact: Natalie Taylor
Saint Louis University, MO, United States
Contact: Susan Brown
Washington University School of Medicine, MO, United States
Contact: Rebecca Livigni
United States, Nebraska
Neurology Associates, P.C. Somnos Clinical Research, NE, United States
Contact: Desirae Eschiti
University of Nebraska Medical Center, NE, United States
Contact: Katelyn Hilz
United States, Nevada
Las Vegas Clinic, NV, United States
Contact: Richa Priya Jha
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, NH, United States
Contact: Jessica Kemmet
United States, New Jersey
Hackensack University Medical Center, NJ, United States
Contact: Michelle Williams
United States, New York
Columbia University, NY, United States
Contact: Oneika Blackman
Stony Brook University, NY, United States
Contact: Christine Pol
SUNY Upstate, NY, United States
Contact: Lena Deb
United States, North Carolina
Duke University, NC, United States
Contact: Michelle Ward
Wake Forest University Health Sciences, NC, United States
Contact: Mozhdeh Marandi
United States, Ohio
Cleveland Clinic, OH, United States
Contact: Matt Tainer or
Ohio State University, OH, United States
Contact: Cheyenne Grove
University of Cincinnati, OH, United States
Contact: Ashley Smith
United States, Oregon
Providence Brain and Spine Institute ALS Center, OR, United States
Contact: Ashley Adamo
United States, Pennsylvania
Jefferson Weinberg ALS Center, Thomas Jefferson University, PA, United States
Contact: Daniel Kelly
Lehigh Valley Health Network, PA, United States
Contact: Kevin Stanley
Lewis Katz School of Medicine, Temple University, PA, United States
Contact: Kathleen Hatala
Penn State Hershey, PA, United States
Contact: Michele Hare
University of Pennsylvania, PA, United States
Contact: Adreeja Guharay
University of Pittsburgh Medical Center, PA, United States
Contact: Jaquelynn Jones
United States, Tennessee
Vanderbilt University Medical Center, TN, United States
Contact: Diana Davis
United States, Texas
Houston Methodist, TX, United States
Contact: Anjana Singh
Texas Neurology, TX, United States
Contact: Mohamad Asaad Nasri
University of Texas Health Science Center at San Antonio (UTHSCSA), TX, United States
Contact: Randee Kent-Baron
United States, Utah
University of Utah, UT, United States
Contact: Crystal Neate
United States, Virginia
University of Virginia, VA, United States
Contact: Mary Wagoner
Virginia Commonwealth University, VA, United States
Contact: LaVon Smith
United States, Washington
Swedish Medical Center, WA, United States
Contact: Janae Rahiman
University of Washington, WA, United States
Contact: Kassie Chu
United States, Wisconsin
Medical College of Wisconsin, WI, United States
Contact: Marie Mejaki
United States,
Indiana University, United States
Contact: Sandy Guingrich
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥ 50%
Months Since Onset
Number of months since first symptoms of ALS.
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Not Available
Open Label
Update Notes
Press release that 1st participant dosed
Updated outcome measures

Other Information

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. Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.
Inclusion Criteria:
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Exclusion Criteria:
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
1. Diagnosis of epilepsy or seizure within 6 months of randomization 2. Hypersensitivity to DNL343 or any of the excipients contained within the DNL343 drug product 3. The concomitant use of prescription or over-the-counter (OTC) medications that are inducers of certain cytochrome P450 enzymes, substrates of certain cytochrome P450 enzymes, or substrates of certain drug transporters.
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. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen. If a participant is randomized to Regimen G DNL343, the participant will complete a screening visit to assess additional Regimen G eligibility criteria. Once Regimen G eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active DNL343 or matching placebo. Regimen G will enroll by invitation, as participants may not choose to enroll in Regimen G. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen G. For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.
Trial Protocol as Published on
NCT05842941 (First Published: 4/24/2023)