Notice Number: NOT-NS-13-036

Update: The following update relating to this announcement has been issued:

• August 30, 2013 - See Issuance of PAR-13-343 NeuroNEXT Clinical Trials (U01).

Key Dates
Release Date: July 16, 2013
Estimated Publication Date of Announcement: September, 2013
First Estimated Application Due Date: December 2, 2013
Earliest Estimated Award Date: June, 2014
Earliest Estimated Start Date: July, 2014

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The NINDS intends to reissue PAR-11-343 to solicit applications for NeuroNEXT Clinical Trials (U01).

The revised Funding Opportunity Announcement (FOA) is expected to be published in Fall 2013 with an expected initial application due date in December 2013.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators to begin to consider applying for this revised FOA.

The revised FOA will encourage applications for biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices that may contribute to the justification for and provide the data required to design a subsequent trial to further evaluate the intervention. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. Applications for devices may propose early or traditional feasibility studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

D. Elizabeth McNeil, MD MSc
National Institute of Neurological Disorders & Stroke
Telephone: 301-496-9135
Email: [email protected]