Medgenics Presents New Data Showing Prevalence of Genetic Mutations in Pediatric Populations with Attention Deficit Hyperactivity Disorder
"There is increasing interest in the critical role of glutamate neurotransmission in ADHD and other neuropsychiatric disorders," said
A total of 23 investigators in centers across the
"The results of this study support our ongoing Phase 2/3 interventional adolescent ADHD trial, known as SAGA" said
ADHD is the most common neurodevelopmental disorder of childhood and is generally characterized as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. Approximately 11% – or 6.4 million – of U.S. children (4-17 years of age) have been diagnosed with ADHD, according to a recent study conducted by the
Poster 6.67: Glutamatergic Network Gene Mutations in Adolescents and Children with Attention Deficit Hyperactivity Disorder (ADHD)
An abstract of the accepted presentation can be accessed on AACAP's 63rd Annual Meeting website.
About the SAGA Trial
The purpose of this multicenter, dose-optimized trial in adolescents with ADHD is to confirm the results from the Phase 1b GREAT study. The trial is designed as a randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study of NFC-1 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial will enroll 90 patients between the ages of 12 to 17 years old. The primary and key secondary endpoints in the trial will be the change from baseline in the ADHD-rating scale Total Score (ADHD-RS-5) and change from baseline in Clinical Global Impression - Global Improvement Scale (CGI-I). Patients will be randomized 1:1 to receive either a six-week course of NFC-1 or placebo, with a one-week follow-up. Patients will be enrolled from the same 25 sites that were used in the recent phenotype/genotype study. More information on the SAGA trial is available at www.ClinicalTrials.gov (Identifier: NCT02777931).
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