Medgenics Announces Enrollment of First Patient in Phase 2/3 Clinical Trial of NFC-1 in Adolescents With mGluR Mutation Positive ADHD
"Enrollment of our first patient is a critical milestone for
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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