The FY25 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award is a funding initiative under the U.S. Department of Defense’s (DOD) Congressionally Directed Medical Research Programs (CDMRP). Managed by the U.S. Army Medical Research and Development Command (USAMRDC), this program was launched to support research with high potential impact on the treatment and management of Amyotrophic Lateral Sclerosis (ALS). Since its inception in 2007, the ALSRP has received over $269 million in appropriations, with $40 million allocated for FY25.

This funding opportunity aims to support early-phase clinical trials, specifically Phase 1 to small-scale Phase 2 trials, focused on innovative therapeutic strategies and improvements in ALS care. Two major focus areas are emphasized: Biomarker-Driven Interventions and Clinical Care. Projects under the Biomarker-Driven Interventions must utilize biomarkers that demonstrate mechanistic relevance to the intervention, helping de-risk and inform future trial designs. Clinical Care projects aim to enhance symptom management and clinical practices affecting ALS patients. Regardless of the focus, all applicants must integrate a Community Collaboration Plan involving persons living with ALS, caregivers, or relevant community-based organizations.

The total anticipated funding for this opportunity is approximately $6.6 million, with a maximum of two awards expected. Each award provides up to $2 million in direct costs over a maximum three-year performance period. Applications must include comprehensive plans for project execution, including community collaboration, regulatory strategies, biomarker use (if applicable), and post-award transition strategies. The trials are expected to begin within 12 months of award, or 18 months if FDA-regulated.

Eligibility is broad, allowing applications from both domestic and international entities, including for-profit, non-profit, public, and private organizations. Independent investigators at all career levels may serve as Principal Investigators. Submission involves a two-step process: a pre-application due by June 6, 2025, and, upon invitation, a full application due by August 27, 2025. Applications must be submitted via eBRAP or Grants.gov, depending on the organizational type.

Evaluation of applications includes both peer and programmatic review phases. The peer review assesses technical merit based on criteria like clinical impact, scientific rationale, trial design, recruitment feasibility, and statistical rigor. Programmatic review evaluates alignment with ALSRP goals, innovation, and potential for broad impact. Each submission must also demonstrate data sharing plans, commitment to inclusive study populations, and thoughtful ethical considerations.

For support, applicants can contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507, and the Grants.gov Contact Center at support@grants.gov or 800-518-4726. Full details, including required application documents and templates, are accessible via the eBRAP portal and CDMRP websites. The award announcement is expected no later than September 30, 2026, with funding usable through September 30, 2031.