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A 6-week, Randomized, Multicenter, Double-blind, Parallel, Flexed and Fixed-dose Study of MG01CI (Metadoxine Extended-release) Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome

Trial Profile

A 6-week, Randomized, Multicenter, Double-blind, Parallel, Flexed and Fixed-dose Study of MG01CI (Metadoxine Extended-release) Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Metadoxine (Primary)
  • Indications Fragile X syndrome; Mental retardation
  • Focus Therapeutic Use
  • Sponsors Alcobra

Most Recent Events

  • 03 Jul 2016 Status changed from active, no longer recruiting to completed.
  • 12 Nov 2015 According to an Alcobra media release, the results from this trial will be sufficient to support a claim of efficacy for the approval of metadoxine.
  • 24 Jun 2015 Results published in an Alcobra media release.

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