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SHARE: 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 CudkowiczRotating 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

**Current**

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**Alumni**

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:

Academic and industry investigators may apply for NeuroNEXT Clinical Trials (OTA-24-013(pdf, 311 KB)).
	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:

**NINDS Exploratory Clinical Trials** (PAR-22-142)
	**NINDS Efficacy Clinical Trials** (PAR-21-237)

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

NeuroNEXT is pleased to announce twoResearch 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 Researchhyunjoo.cho@nih.gov

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

NN 109 MAGINE (A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of ManNAc in Subjects with GNE Myopathy
	NN 111 The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis**Completed**

NN 101 SMA biomarkers study
	NN 102 SPRINT-MS
	NN 103 Beat MG
	NN 104 RHAPSODY
	NN 105 STAIR (SRX246: Safety, Tolerability, and Activity in IRritable subjects with HD)
	NN 106 CYTO-C (Cytochrome C Oxidase: Biomarker in Newly Diagnosed Glioblastoma Multiforme)
	NN 107 Effects of AFQ056 on Language Learning in Young Children with Fragile X Syndrome
	NN 108 TopCSPN (Topiramate as a Disease Altering Therapy for CSPN)
	NN 110 A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson’s DiseaseResources and Tools

Contacts

Sophie Cho, M.D.
Program Director, Division of Clinical Researchhyunjoo.cho@nih.gov Current Research
  
    

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