Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
a multi‐center, randomized, double‐blind, placebo‐controlled, parallel‐arm design, laboratory classroom (LC) clinical trial to evaluate the safety and efficacy of NRCT‐101SR (up to to 2,000 mg/day based on LBM) over a 6‐week period in approximately 160 pediatric subjects (13���17 years of age) with ADHD. An open label extension (OLE) of 6 weeks will be optional. Selected sites will collect blood samples for PK from a subset of subjects. The primary endpoint of the study is Permanent Product Measure of Performance (PERMP) Math Tests and the key secondary endpoint is ADHD Rating Scale (ADHD‐RS). The primary analysis will be on effects of 6‐week treatment of NRCT‐101SR versus placebo on performance (PERMP) in subjects with ADHD.
Epistemonikos ID: dca311327f2b56f98911c3c22ef3d57cb1697d56
First added on: May 15, 2024