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Now Accepting Applications for the 2025 NEALS ALS CRLI
Application Portal now open!
NEALS is pleased to announce the 2025 ALS Clinical Research Learning Institute, a two-day in-person program in Clearwater, Florida (October 6–7), designed to educate and empower individuals impacted by ALS—including people living with ALS, caregivers, and family members—to engage in clinical research and the therapy development process.
Our Mission
Our mission is to accelerate the development of new treatments through innovative research and working collaboratively with people living with ALS and all stakeholders in the ALS research community.
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With support from The ALS Association, NEALS provides up-to-date information for finding both federally and privately funded clinical studies focusing on ALS and MND.
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Educational Webinars
Current Trials
Recruiting
Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial
Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803, neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg)…Recruiting
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor…Recruiting
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients with Amyotrophic…Recruiting
Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Proof of Concept Trial Including Asymptomatic Individuals Using Baricitinib
This is an open-label, biomarker-driven basket trial of baricitinib in people with subjective cognitive disorder, mild cognitive impairment, Alzheimer's disease (AD), Amyotrophic lateral sclerosis…Recruiting
The Effects of Rehabilitation on Functional Outcomes in Patients With SOD1 ALS Treated With Tofersen
The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program.…Recruiting
A Phase 1/2 Two-center, Double-blind, Randomized, Placebo-controlled Multi-period Crossover (N-of-1) Study to Evaluable the Feasibility, Safety, and Efficacy of TJ-68 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps
The primary objective of the study is to demonstrate the safety and potential efficacy of TJ-68 for improving muscle cramps in participants with ALS based on a two-site, randomized,…Trials News & Events
FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS
FDA granted accelerated approval of QALSODY based on a reduction of neurofilament, a marker of neurodegeneration.
The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and Rapa Therapeutics have announced the first participant enrolled in the Expanded Access to RAPA-501 Protocol (EAP)
The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and Rapa Therapeutics have announced the first participant enrolled in the Expanded Access to RAPA-501 Protocol (EAP). This EAP is sponsored by the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS), as part of the U.S. government’s landmark Accelerating Access to Critical Therapies for ALS Act (ACT for ALS).
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Groundbreaking Directive Ensures ALS Patients on Medicare Advantage Gain Access to Qalsody
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First Participant Enrolled in NIH-Funded Access for All in ALS Consortium
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Transposon Announces Final Results from a Phase 2 Study of TPN-101 for the Treatment of C9orf72-Related Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia
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Healey & AMG Center for ALS Announces New Investigational Drug Monepantel from PharmAust Limited will begin design for inclusion in HEALEY ALS Platform Trial