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.
NeuroNEXT Executive Committee (NEC)
Permanent members
- Christopher S. Coffey
- Merit Cudkowicz
Rotating members
- Dr. John Kissel
- Robert G. Holloway, M.D.
- Mark Goldberg
- Robert Fox, M.D.
- Marianne Kearney
- Stephen J. Kolb, M.D.
- Dixie Ecklund
- Richard Nowak, M.D.
- Patrick Lyden, M.D.
Data Coordinating Center: University of Iowa
Clinical Coordinating Center: Massachusetts General Hospital
NeuroNEXT Clinical Sites
- Albert Einstein College of Medicine Yeshiva University
- Children’s Hospital - Boston
- Children’s National Medical Center
- Columbia University – Weill Cornell
- Emory University
- Harvard Partners (Brigham and Women's Hospital, Massachusetts General Hospital)
- Northwestern University
- Ohio State University
- Oregon Health and Science University
- SUNY (Buffalo, Downstate, Upstate, and Stony Brook)
- Swedish Neuroscience Institute - Seattle
- University of Alabama at Birmingham
- University of California - Davis
- University of California – Los Angeles
- University of Cincinnati
- University of Colorado - Denver
- University of Kansas Medical Center
- University of Miami School of Medicine
- University of Pittsburgh
- University of Rochester
- University of Texas Southwestern Medical Center at Dallas
- University of Utah
- University of Virginia – Charlottesville
- Vanderbilt University
- Washington University in St. Louis School of Medicine
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 OCR in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure.
There are two mechanisms available for potential applicants:
- Academic investigators may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-18-528).
- Small businesses may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-18-528); OR through our Small Business program: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-18-628).
Information for potential industry collaborators:
- PDF of the slides for industry(pdf, 888 KB) - presented at the October 7, 2011 webinar
Information for potential advocacy collaborators:
- PDF of the slides for advocacy(pdf, 881 KB) - presented at the October 14, 2011 webinar
Potential applicants whose clinical research cannot be supported through NeuroNEXT are encouraged to consider an alternate funding mechanism:
- NINDS Exploratory Clinical Trials (PAR-18-420)
- NINDS Efficacy Clinical Trials (PAR-18-422)
Referral/Review Process for NeuroNEXT Applications
- Prospective applicant contacts NINDS/OCR to discuss the proposed trial:
Sophie Cho, M.D.
Program Director, Division of Clinical Research
hyunjoo.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 feasibility
- Projects that have NINDS program support and are feasible for network performance are asked to submit a formal application for peer review by the NeuroNEXT SEP and subsequent consideration by the NINDS Advisory Council. The NeuroNEXT CCC will assist in protocol development in support of the formal application.
- NeuroNEXT Clinical Trials (U01) - Standard dates apply for scientific merit review of applications coming under the U01 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-18-528.
- 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-18-628.
Current NeuroNEXT-supported Studies
Completed
- NN-102 SPRINT-MS
- NN103 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 109- MAGINE (A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of ManNAc in Subjects with GNE Myopathy
- NN 110 – A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson’s Disease
Resources and Tools
Contacts
Sophie Cho, M.D.
Program Director, Division of Clinical Research
hyunjoo.cho@nih.gov
Questions? NEXT@ninds.nih.gov