Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

Source-based overview

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics) ). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects. The official record contains the controlling eligibility, budget, attachment and submission requirements for opportunity RFA-NS-28-009.

Eligibility

Eligible applicant types listed by the agency: State governments; Small businesses; Private institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); For profit organizations other than small businesses; City or township governments; Public and State controlled institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); Special district governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Native American tribal governments (Federally recognized); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education. Applicants must also satisfy every programme-specific condition in the official notice.

Funding and benefits

Estimated programme funding: See official notice

Themes and supported activities

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics) ). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.

Opportunity number: RFA-NS-28-009

Deadline and timeline

Forecast notice: deadline to be announced: Forecast notice: deadline to be announced.

Applicants should confirm the exact deadline time, time zone, required documents, portal steps and any institutional approvals on the official call page before submitting.

How to apply

Open the official Grants.gov record, review the full notice and attachments, and use the application package or agency route stated there.

Before applying, check eligibility rules, budgets, attachments, page limits, partner requirements, cost-share conditions and whether the opportunity uses an expression of interest, full proposal, registration or nomination stage.