Atom | DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

Due Dates: June 6, 2025 (Pre-application) | August 27, 2025 (Full application, by invitation only)

Funding Amounts: Up to $2.8M total costs per award over 3 years; approx. 2 awards; total program funding $5.6M.

Summary: Supports rapid pilot clinical trials for ALS interventions or care, emphasizing biomarker-driven strategies or clinical care improvements.

Key Information: Requires a Community Collaboration Plan and must directly support a clinical trial (Phase 1 or small-scale Phase 2).

Description

This opportunity from the Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential for significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may be phase 1 or small-scale phase 2 clinical trials. Proposals must address one of two focus areas: biomarker-driven interventions (requiring mechanism-specific biomarkers) or improvements in clinical care and symptom management for ALS. All applications must include a Community Collaboration Plan to ensure meaningful patient and stakeholder engagement.

Due Dates

Pre-application deadline: June 6, 2025 (5:00 p.m. ET) via eBRAP
Invitation to submit full application: July 10, 2025
Full application deadline: August 27, 2025 (11:59 p.m. ET) via Grants.gov (extramural applicants) or eBRAP (intramural DOD only)
Peer review: October 2025
Programmatic review: December 2025

Funding Amount

Total funding available: $5,600,000
Number of awards: Approximately 2
Maximum funding per award: $2,800,000 total costs (direct + indirect) for up to 3 years
No cost-sharing required
Funding must be used to support a clinical trial (not preclinical research)

Eligibility

Eligible organizations:
- Domestic and foreign, for-profit and non-profit organizations, public or private entities, including academic institutions, biotechnology companies, foundations, federal government organizations (except DOD intramural for extramural track), and research institutes.
Principal Investigator:
- Independent investigators at any career level; must be affiliated with an eligible organization.
- No restrictions on citizenship or nationality.
Additional requirements:
- The project must be a clinical trial (phase 1 or small phase 2).
- Must include a Community Collaboration Plan.
- For therapeutic interventions, biomarker integration is required.
- Must have active registrations in SAM.gov, eBRAP, and (for extramural) Grants.gov.

Application Process

Step 1: Pre-Application (Required)

Submit via eBRAP
Components: Preproposal narrative (3 pages), references, list of abbreviations, biographical sketches
Deadline: June 6, 2025
Only invited applicants may proceed to the full application.

Step 2: Full Application (By Invitation Only)

Submit via Grants.gov (extramural) or eBRAP (intramural DOD)
Components include:
- Project narrative (15 pages)
- Supporting documentation
- Abstracts (technical and lay)
- Statement of Work
- Study Population Recruitment and Safety Plan
- Regulatory strategy
- Study personnel and organization details
- Community Collaboration Plan (required)
- Impact statement
- Post-award transition plan
- Biomarker statement (for biomarker-driven focus)
- Required representations (Grants.gov)
- Budget and justification
- Biographical sketches and current/pending support
Key attachments and templates are detailed in the program announcement.

Additional Notes

Clinical trial must begin within 12 months of award (or 18 months for FDA-regulated studies).
Projects must demonstrate access to the intervention and patient population.
Applications not meeting requirements (e.g., missing Community Collaboration Plan, not a clinical trial, lacking biomarker integration for relevant focus) will be administratively withdrawn.

Additional Information

Focus Areas:
- Biomarker-Driven Interventions: Must include mechanism-specific biomarkers to de-risk and inform larger trials.
- Clinical Care: Projects to improve clinical care or symptom management for ALS.
Community Collaboration: Applicants must partner with people living with ALS, caregivers, or community organizations throughout the project lifecycle.
No preclinical-only studies allowed.
Peer and programmatic review process applies.
Awards are made to organizations, not individuals.

External Links

Contact Information

Contact	Email	Phone	Purpose
CDMRP Help Desk	help@eBRAP.org	301-682-5507	Program and technical questions, eBRAP help
Grants.gov Contact Ctr	support@grants.gov	800-518-4726	Grants.gov registration and submission help