Phase I Single Dose, Open-label, Pharmacokinetic Study Followed by Single-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Plasma Concentration Profiles, and Targeted Efficacy of NFC-1 in Adolescents (12-17 Years of Age) With Attention-Deficit Hyperactivity Disorder and Genetic Disruption Impacting Metabotropic Glutamate Receptor Genes (NFC1-GREAT)

Trial Profile

Phase I Single Dose, Open-label, Pharmacokinetic Study Followed by Single-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Plasma Concentration Profiles, and Targeted Efficacy of NFC-1 in Adolescents (12-17 Years of Age) With Attention-Deficit Hyperactivity Disorder and Genetic Disruption Impacting Metabotropic Glutamate Receptor Genes (NFC1-GREAT)

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Dec 2016

At a glance

  • Drugs Fasoracetam (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms NFC1-GREAT
  • Sponsors Medgenics; NeuroFix Therapeutics
  • Most Recent Events

    • 10 May 2016 According to Medgenics media release, following positive data from this study, company has initiated phase II/III (700260746) trial.
    • 22 Oct 2015 Results will be presented at the upcoming 62nd Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) meeting, as per Medgenics media release.
    • 22 Oct 2015 Status changed from active, no longer recruiting to completed, as per Medgenics media release.
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