{"id":3992,"date":"2019-02-08T17:43:51","date_gmt":"2019-02-08T06:43:51","guid":{"rendered":"https:\/\/rettaustralia.org.au\/?p=3992"},"modified":"2021-08-25T20:28:51","modified_gmt":"2021-08-25T10:28:51","slug":"phase-3-trial-of-trofinetide-will-take-place-in-the-us-during-the-latter-half-of-2019","status":"publish","type":"post","link":"https:\/\/rettaustralia.org.au\/blog\/phase-3-trial-of-trofinetide-will-take-place-in-the-us-during-the-latter-half-of-2019\/","title":{"rendered":"Phase 3 trial of trofinetide will take place in the US during the latter half of 2019"},"content":{"rendered":"\r\n

4 February 2019<\/strong> – Neuren Pharmaceuticals advised the Australian Stock Exchange, Melbourne, of a statement released by ACADIA Pharmaceuticals about its plans for the Phase 3 trial of trofinetide in Rett syndrome. As with Phases 1 and 2, the trial will be held in the US. In part, ACADIA stated that<\/p>\r\n\r\n\r\n\r\n

“We would like to share our plans for the Phase 3 study of trofinetide for Rett syndrome starting in the second half of 2019 which have now been confirmed. <\/em><\/p>\r\n\r\n\r\n\r\n

 ACADIA plans to conduct a three-month Phase 3, double-blind, randomized, placebo-controlled study to evaluate efficacy and safety of trofinetide and placebo in approximately 180 females ages 5 to 20 years with Rett syndrome. Half of the study participants will receive trofinetide and half will receive placebo<\/em><\/p>\r\n\r\n\r\n\r\n

…………………………….  <\/em>The Phase 3 study will be followed by an open label extension study in which all participants, including those on placebo in the Phase 3 study, will be eligible to receive trofinetide. In the open label extension study, all participants will be followed to evaluate long term tolerability and safety of trofinetide………………………. <\/em>The ACADIA Rett Team<\/em>“.<\/p>\r\n\r\n\r\n\r\n

Background<\/h4>\r\n\r\n\r\n\r\n

In the beginning
<\/em>Distinguished Professor Dame Margaret Brimble, co-creator of NNZ-2566 which was to be later renamed trofinetide, gave a presentation on the drug at Rett New Zealand’s bi-annual family conference which was held in Auckland in May 2014. A recording of her talk can be found by clicking on the following link which is contained on the Rett New Zealand’s website http:\/\/vimeo.com\/102437053<\/a><\/strong><\/p>\r\n\r\n\r\n","protected":false},"excerpt":{"rendered":"

4 February 2019 – Neuren Pharmaceuticals advised the Australian Stock Exchange, Melbourne, of a statement released by ACADIA Pharmaceuticals about its plans for the Phase 3 trial of trofinetide in Rett […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","ngg_post_thumbnail":0,"footnotes":""},"categories":[8,12],"tags":[],"taxonomy_info":{"category":[{"value":8,"label":"All News Posts"},{"value":12,"label":"Clinical Trials"}]},"featured_image_src_large":false,"author_info":{"display_name":"Gary Grocott","author_link":"https:\/\/rettaustralia.org.au\/author\/garyg\/"},"comment_info":0,"category_info":[{"term_id":8,"name":"All News Posts","slug":"news","term_group":0,"term_taxonomy_id":8,"taxonomy":"category","description":"","parent":0,"count":40,"filter":"raw","cat_ID":8,"category_count":40,"category_description":"","cat_name":"All News Posts","category_nicename":"news","category_parent":0},{"term_id":12,"name":"Clinical Trials","slug":"clinical-trials","term_group":0,"term_taxonomy_id":12,"taxonomy":"category","description":"","parent":0,"count":6,"filter":"raw","cat_ID":12,"category_count":6,"category_description":"","cat_name":"Clinical Trials","category_nicename":"clinical-trials","category_parent":0}],"tag_info":false,"_links":{"self":[{"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/posts\/3992"}],"collection":[{"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/comments?post=3992"}],"version-history":[{"count":1,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/posts\/3992\/revisions"}],"predecessor-version":[{"id":5416,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/posts\/3992\/revisions\/5416"}],"wp:attachment":[{"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/media?parent=3992"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/categories?post=3992"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rettaustralia.org.au\/wp-json\/wp\/v2\/tags?post=3992"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}