NeuroNEXT: Network for Excellence in Neuroscience Clinical Trials

NeuroNEXT will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. The network includes multiple Clinical Sites, one Clinical Coordinating Center (CCC) and one Data Coordinating Center (DCC).

You DO NOT need to be part of the NeuroNEXT infrastructure to apply to conduct a study within the network. Applications from academic investigators, advocacy groups/foundations, small businesses and the pharmaceutical industry are welcomed.

Please join our upcoming webinar: May 2, 2024, 1-2pm ET

This webinar will provide information on NeuroNEXT's new two-stage application and review process and offer a forum for potential applicants to ask questions.

Register now for the webinar!

NeuroNEXT Executive Committee (NEC)

Permanent members
  • Christopher S. Coffey
  • Merit Cudkowicz
Rotating members
  • Anthony Amato
  • Brenda Banwell
  • Stacey Clardy
  • Angie Molloy
  • Aleks Videnovic
  • Dan Woo
  • Claudia Chiriboga

Data Coordinating Center: University of Iowa

Clinical Coordinating Center: Massachusetts General Hospital

NeuroNEXT Clinical Sites


  • Barrow (St. Joseph's Hospital & Medical Center, Dignity Health & Phoenix Children's Hospital)
  • Children’s Hospital - Boston
  • Columbia University – Weill Cornell
  • Harvard Partners (Brigham and Women's Hospital, Massachusetts General Hospital)
  • Icahn School of Medicine at Mount Sinai
  • Northwestern University
  • Ohio State University
  • SUNY (Buffalo and Stony Brook)
  • University of Alabama at Birmingham
  • University of California - Davis
  • University of California - Irvine
  • University of Cincinnati
  • University of Iowa
  • University of Miami School of Medicine
  • University of Michigan at Ann Arbor
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Rochester
  • University of Texas Southwestern Medical Center at Dallas
  • University of Utah
  • University of Virginia – Charlottesville
  • Vanderbilt University
  • Wake Forest University
  • Washington University in St. Louis School of Medicine
  • Yale University


  • Albert Einstein College of Medicine Yeshiva University
  • Children’s National Medical Center
  • Emory University
  • Oregon Health and Science University
  • Swedish Neuroscience Institute - Seattle
  • University of California – Los Angeles
  • University of Colorado - Denver
  • University of Kansas Medical Center


How to Apply to NeuroNEXT

NeuroNEXT is intended to facilitate the testing of novel therapeutics (drugs, biologics, devices) for neurological disorders. These novel therapeutics may come from academic investigators or directly from the biotechnology or pharmaceutical sector. NeuroNEXT aims to support scientifically sound phase 2 clinical trials that provide data for clear go/no-go decisions. Biomarker validation studies are also considered either independently or as part of a therapeutic trial.

Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant. NINDS will provide guidance to potential applicants with input from the Division of Clinical Research (DCR), the applicable NINDS Extramural office/cluster and the NeuroNEXT Executive Committee (NEC). Potential applicants should contact NINDS DCR in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure.

There are two mechanisms available for potential applicants:

  1. Academic and industry investigators may apply for NeuroNEXT Clinical Trials (OTA-24-013(pdf, 311 KB)).
  2. Small businesses may apply for NeuroNEXT Clinical Trials (OTA-24-013(pdf, 311 KB)); OR through our Small Business program: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-21-224).

Potential applicants whose clinical research cannot be supported through NeuroNEXT are encouraged to consider an alternate funding mechanism:


New Research Opportunity Announcements for Ultra-rare Gene-based Therapy (URGenT) Clinical Trials conducted within NeuroNEXT

NeuroNEXT is pleased to announce two Research Opportunity Announcements (ROAs) to support clinical trials of gene-based and gene-targeted therapies for ultra-rare neurological diseases.  The URGenT Clinical Trials program will utilize a two-stage application and review process for therapeutics that have an active Investigational New Drug (IND) designation.  Stage 1 applications (OTA-24-011(pdf, 283 KB)) will include scientific background information supporting the gene-therapy product/therapeutic and proposed clinical trial.  Stage 2 Protocol Applications (OTA-24-012(pdf, 381 KB)) will be accepted by invitation only and will include the submission of more detailed information on the proposed clinical trial and related activities. Potential applicants are STRONGLY encouraged to contact NeuroNEXT/URGenT Program Staff to discuss their application and the application process prior to submission.

Referral/Review Process for NeuroNEXT Applications

  • Prospective applicant contacts NINDS/DCR to discuss the proposed trial:

Sophie Cho, M.D.
Program Director, Division of Clinical Research

  • NINDS program staff will discuss the proposed trial.
  • Trials that have good NINDS program support are referred to the NEC to assess network suitability.
  • NeuroNEXT Clinical Trials (OTA) - Applications are accepted on a rolling basis. 
    • Projects that have NINDS program support and are suitable for network performance are asked to submit a formal Stage 1 Preliminary Application for independent/objective review. 
    • After successful review of the Stage 1 Preliminary Application and upon receiving an invitation to proceed to Stage 2, the asset holder will work with the NeuroNEXT to further develop the clinical trial protocol.
    • At Stage 2 the NeuroNEXT CCC becomes the applicant of record for the Stage 2 Protocol Application (OTA-24-014(pdf, 836 KB)).
    • NIH funds to conduct the study are awarded to the NeuroNEXT CCC only after successful completion of both stages of application and review, and approval by the NINDS Director following National Advisory Neurological Disorders and Stroke Council review.
  • NeuroNEXT Small Business Innovation in Clinical Trials (U44) - Standard dates apply for scientific merit review of applications coming under the U44 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-21-224.

Current NeuroNEXT-supported Studies


Resources and Tools


Sophie Cho, M.D.
Program Director, Division of Clinical Research