NIH Reporter #5U01NS114312-05

Research and validation of biomarkers and clinical outcome measures for CDKL5 deficiency disorder

This opportunity from the National Institute of Neurological Disorders and Stroke (NINDS), in partnership with the University of Colorado Denver, seeks proposals for research supporting clinical trial readiness in CDKL5 deficiency disorder. - Government Buyer: - National Institute of Neurological Disorders and Stroke (NINDS) - University of Colorado Denver (collaborative partner) - Products/Services Requested: - Research and validation of clinical outcome measures and biomarkers for CDKL5 deficiency disorder - Multi-site clinical trial readiness study - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) are mentioned - Notable Requirements: - Expertise in neurodevelopmental disorders - Ability to conduct multi-site studies - Focus on biomarker and clinical outcome measure validation to facilitate future therapeutic development - Estimated Contract Value: - $782,432 - Period of Performance: - Single-phase research project; specific period not stated, likely annual or project-based

Description

This project involves research and validation of clinical outcome measures and biomarkers for CDKL5 deficiency disorder. It aims to prepare for multi-site clinical trials by developing and validating these measures to support clinical trial readiness. The scope includes a multi-site clinical trial readiness study to facilitate potential therapeutic development for this disorder.

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