A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism.

Trial Profile

A Phase III Randomized Double Blind Placebo Controlled Trial of CM-AT in Children With Autism.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2013

At a glance

  • Drugs CM 4612 (Primary)
  • Indications Autistic disorder
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 04 Nov 2013 Curemark submitted an NDA for CM 4612 to the US FDA.
    • 06 Aug 2012 FDA approves direct enrolment into an open label extension. Not sure how this relates to the extension info that was already in here
    • 30 Sep 2011 Actual end date (Sep 2011) added as reported by ClinicalTrials.gov (Parent trial: NCT00881452).
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