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To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Male or female, 13-17 years of age at screening.
Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmed with MINI using DSM-5 probes.
ADHD-related symptoms - ADHD-RS-5 ≥ 26 in screening and baseline.
* Baseline score must not change by more than 25% from screening to baseline, except subjects who stop taking ADHD medication after screening may have an increase of more than 25%.
Has a minimum score of 4 on the CGI-S at baseline.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups, including a placebo group
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Central trial contact
Mia Taylor, BS; Guy Bar-Klein, PhD
Data sourced from clinicaltrials.gov
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