Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Forecasted
NIH plans to support research using data from expanded access protocols that provide investigational treatments to people with ALS; applications are not yet being solicited.
Funder: National Institutes of Health
Due Dates (Anticipated): May 2027 (Application due)
Funding Amounts: Not specified
Summary: NINDS plans to support ALS research using data from intermediate-size expanded access protocols.
Key Information: Applicants must be clinical trial sites participating in a qualifying phase 2/3 or phase 3 ALS efficacy trial.
Description
The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, plans to support research using data from intermediate-size patient population expanded access protocols for amyotrophic lateral sclerosis (ALS). These protocols should provide people with ALS access to an investigational drug or biological product while generating data for research on preventing, diagnosing, mitigating, treating, or curing ALS.
Research goals may include studying biomarkers related to ALS pathophysiology or target engagement; collecting safety and outcome information, such as survival, hospitalization, or need for ventilatory support; or examining patient experience data not specifically tied to assessing efficacy. The opportunity is forecasted to give potential applicants time to develop responsive projects.
