Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling

Josephine Elia (), Grace Ungal, Charlly Kao, Alexander Ambrosini, Nilsa Jesus-Rosario, Lene Larsen, Rosetta Chiavacci, Tiancheng Wang, Christine Kurian, Kanani Titchen, Brian Sykes, Sharon Hwang, Bhumi Kumar, Jacqueline Potts, Joshua Davis, Jeffrey Malatack, Emma Slattery, Ganesh Moorthy, Athena Zuppa, Andrew Weller, Enda Byrne, Yun R. Li, Walter K. Kraft and Hakon Hakonarson
Additional contact information
Josephine Elia: Nemours, du Pont Hospital for Children
Grace Ungal: Drexel University College of Medicine
Charlly Kao: The Children’s Hospital of Philadelphia
Alexander Ambrosini: University of Pennsylvania
Nilsa Jesus-Rosario: Department of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University
Lene Larsen: Department of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University
Rosetta Chiavacci: The Children’s Hospital of Philadelphia
Tiancheng Wang: The Children’s Hospital of Philadelphia
Christine Kurian: Department of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University
Kanani Titchen: Nemours, du Pont Hospital for Children
Brian Sykes: Nemours, du Pont Hospital for Children
Sharon Hwang: Nemours, du Pont Hospital for Children
Bhumi Kumar: Nemours, du Pont Hospital for Children
Jacqueline Potts: Department of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University
Joshua Davis: Nemours, du Pont Hospital for Children
Jeffrey Malatack: Nemours, du Pont Hospital for Children
Emma Slattery: Department of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University
Ganesh Moorthy: University of Pennsylvania
Athena Zuppa: University of Pennsylvania
Andrew Weller: Department of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University
Enda Byrne: The Children’s Hospital of Philadelphia
Yun R. Li: The Children’s Hospital of Philadelphia
Walter K. Kraft: Department of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University
Hakon Hakonarson: The Children’s Hospital of Philadelphia

Nature Communications, 2018, vol. 9, issue 1, 1-9

Abstract: 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

Date: 2018
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DOI: 10.1038/s41467-017-02244-2

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