# DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

Source: https://welltoldgrants.com/grants/w81xwh-22-alsrp-pcta-dod-amyotrophic-lateral-sclerosis-pilot-clinical-trial-award/  
Official notice: https://www.grants.gov/search-results-detail/338706

> Defense Health Agency Contracting Activity - DHACA offered grants to any type of organization. It expected to make about 3 awards worth $9.6 million in total. Applications closed on July 28, 2022.

| Field | Value |
|---|---|
| Opportunity number | W81XWH-22-ALSRP-PCTA |
| Agency | Defense Health Agency Contracting Activity - DHACA |
| Status | Forecast |
| Deadline | July 28, 2022 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | 3 |
| Total funding | $9.6 million |
| Cost sharing | not required |
| Assistance Listings | 12.420 |

## Who can apply

- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

## What the grant funds

The FY22 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 ALS. Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preclinical data. Potential impact is not whether a therapy is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients. Applicants not investigating a therapeutic, but proposing a clinical trial to optimize established ALS clinical care, must submit under a lower total direct cost Clinical Care Tier. Types of efforts that will be supported under this tier include but are not limited to optimization of respiratory care strategies, improvements to approved devices and assistive technologies, and/or specific symptom management strategies. The capacity for near-term impact on patient care is an important component of the Clinical Care Tier. Funding from this award mechanism must support a clinical trial. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://cdmrp.army.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY22 ALSRP program announcements being offered. For information about these award mechanisms, see https://cdmrp.army.mil/funding/alsrp The requested budget for the clinical trial must be justified and appropriate to the scope proposed. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. Funding for therapeutics must include plans to generate compelling biomarker data.

## Questions people ask

### Is W81XWH-22-ALSRP-PCTA still open?

No. It closed on July 28, 2022. A newer notice is open: HT942526BCRPCREA2, closes November 18, 2026 (11 days left).

### Who can apply for DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award?

Defense Health Agency Contracting Activity - DHACA accepted applications from any type of organization.

### What is the deadline for DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award?

Closed July 28, 2022. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

About $9.6 million in total across about 3 awards.

### Who has won Military Medical Research and Development grants before?

The largest recipients over five fiscal years were The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., The Univeristy of Texas M.D. Anderson Cancer Center, The Johns Hopkins University. The program made 5,470 awards worth $6.9 billion in that time.