DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award
Can you apply?
This grant is for research institutions and organizations conducting clinical trials in amyotrophic lateral sclerosis (ALS). Eligible applicants typically include academic medical centers, research institutes, hospitals, and nonprofit research organizations with capacity to conduct FDA-regulated clinical studies. Projects must be phase 1 to small-scale phase 2 clinical trials addressing either biomarker-driven interventions or clinical care improvements for ALS. All applications require community collaboration and must begin clinical trial work within 12-18 months of award.
Program description
Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) 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. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies.
Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.
All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.
Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- Application (SF-424 or agency equivalent)
- Project Narrative/Research Proposal
- Budget and Budget Narrative
- Regulatory Strategy Plan
- Transition Plan
- Community Collaboration Documentation
- Institutional Biosafety Committee approval (if applicable)
- Institutional Review Board approval or documentation of pending approval
Program contact
- 👤 Jamie Shortall Grant Officer
- 📧 help@eBRAP.org
- 📞 301-619-2393
Funding track record
Recent awards under CFDA 12.420 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$2,265,729,366
-
$800,631,761
-
$74,531,880
-
$67,205,571
-
$53,718,832
-
$34,191,124
-
$24,907,742
-
$21,394,379
-
$19,100,256
-
$19,002,641
Top States by Funding
- MD 10 awards $3,150.1M
- NC 11 awards $132.3M
- FL 8 awards $99.8M
- CA 11 awards $99.3M
- MA 7 awards $75.2M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 12.420). How funding has trended year over year.
| 2024 | $1,483,968,520 | |
| 2025 | $1,201,153,417 |
FAQ
What types of clinical trials are funded?
This program supports phase 1 to small-scale phase 2 trials. Projects must address biomarker-driven interventions or clinical care improvements for ALS.
Is cost sharing required?
No cost sharing is required for this award.
When must the clinical trial begin?
Trials must begin no later than 12 months after award, or 18 months for FDA-regulated studies.
What regulatory requirements apply?
All applications must include a detailed Regulatory Strategy plan for obtaining approvals and a Transition Plan describing advancement beyond the funded work.
How important is community collaboration?
Community collaboration is required for all applications to optimize research impact.
💡 Tips for applicants
- Clearly identify which focus area your project addresses: biomarker-driven interventions or clinical care improvements for ALS.
- Develop a detailed timeline that realistically shows trial initiation within 12-18 months of award, accounting for regulatory approval processes.
- Integrate biomarkers into your trial design if proposing a therapeutic intervention. This strengthens competitiveness significantly.
- Establish community collaboration partnerships early and document how they will advise and inform your research.
- Plan your transition strategy before writing the application, showing clear next steps beyond the pilot phase.
⚠️ Common mistakes
Applications fail when clinical trial startup timeline is unrealistic for regulatory approval processes. Therapeutic intervention proposals without specific biomarkers integrated into design are weak. Insufficient detail on regulatory strategy or transition plans weakens applications significantly.
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