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Neuren Pharmaceuticals Ltd Receives Approval From US FDA To Conduct Phase 2 Clinical Trial of NNZ-2566 In Patients With Fragile X Syndrome

Sunday, 8 Sep 2013 09:24pm EDT 

Neuren Pharmaceuticals Ltd announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial of NNZ-2566 in patients with Fragile X Syndrome. Neuren intends to initiate the trial before the end of 2013. Adolescent and adult males will be enrolled in a double-blind, placebo-controlled study, which will test two different dose levels of NNZ-2566. Preparations for the study, including clinical site qualification and selection, are well underway. Enrolment is expected to be completed by the end of 2014, with top-line results announced in the first half of 2015. 

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28 Jul 2014