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Journal article
Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling
Nature communications
16 Jan 2018
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The glutamatergic neurotransmitter system may play an important role in attention-deficit hyperactivity disorder (ADHD). This 5-week, open-label, single-blind, placebo-controlled study reports the safety, pharmacokinetics and responsiveness of the metabotropic glutamate receptor (mGluR) activator fasoracetam (NFC-1), in 30 adolescents, age 12–17 years with ADHD, harboring mutations in mGluR network genes. Mutation status was double-blinded. A single-dose pharmacokinetic profiling from 50–800 mg was followed by a single-blind placebo at week 1 and subsequent symptom-driven dose advancement up to 400 mg BID for 4 weeks. NFC-1 treatment resulted in significant improvement. Mean Clinical Global Impressions-Improvement (CGI-I) and Severity (CGI-S) scores were, respectively, 3.79 at baseline vs. 2.33 at week 5 (P < 0.001) and 4.83 at baseline vs. 3.86 at week 5 (P < 0.001). Parental Vanderbilt scores showed significant improvement for subjects with mGluR Tier 1 variants (P < 0.035). There were no differences in the incidence of adverse events between placebo week and weeks on active drug. The trial is registered at https://clinicaltrials.gov/ct2/show/study/NCT02286817.
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Details
- Title
- Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling
- Creators
- Josephine Elia - Alfred I. duPont Hospital for ChildrenGrace Ungal - Drexel UniversityCharlly Kao - Children's Hospital of PhiladelphiaAlexander Ambrosini - University of PennsylvaniaNilsa De Jesus-Rosario - Thomas Jefferson UniversityLene Larsen - Thomas Jefferson UniversityRosetta Chiavacci - Children's Hospital of PhiladelphiaTiancheng Wang - Children's Hospital of PhiladelphiaChristine Kurian - Thomas Jefferson UniversityKanani Titchen - Alfred I. duPont Hospital for ChildrenBrian Sykes - Alfred I. duPont Hospital for ChildrenSharon Hwang - Alfred I. duPont Hospital for ChildrenBhumi Kumar - Alfred I. duPont Hospital for ChildrenJacqueline Potts - Thomas Jefferson UniversityJoshua Ian DavisJ Jeffrey MalatackEmma Slattery - Thomas Jefferson UniversityGanesh S Moorthy - Raymond and Ruth Perelman School of Medicine at the University of PennsylvaniaAthena F Zuppa - Raymond and Ruth Perelman School of Medicine at the University of PennsylvaniaAndrew Weller - Thomas Jefferson UniversityEnda Byrne - Children's Hospital of PhiladelphiaYun R Li - Children's Hospital of PhiladelphiaWalter K Kraft - Thomas Jefferson UniversityHakon Hakonarson - Children's Hospital of Philadelphia
- Publication Details
- Nature communications
- Publisher
- Nature
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:000422648900001
- Scopus ID
- 2-s2.0-85040810967
- Other Identifier
- 991021881388704721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Pharmacology & Pharmacy