Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials.

Applications must address one of the following focus areas:

Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway.

Clinical Care: Improving aspects of clinical care and symptom management for ALS.

Distinctive Features: Funding from this award mechanism must support a clinical trial.

Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.

All applications are required to incorporate a Community Collaboration Plan, as described in Attachment 8 to optimize research impact.

The clinical trial should begin no later than 12 months after the award date or 18 months for FDA-regulated studies.

Miscellaneous

• Unrestricted