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Friday, December 20, 2019 3:17:48 PM
To offer all participants access to ANAVEX®2-73 (blarcamesine) after completion of the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome study[1] and the AVATAR Rett syndrome study[2], 12-week and 48-week open-label extension studies, respectively were initiated. Currently 90% and 100% of eligible participants have continued into the corresponding extension studies.
Above is likely latest and correct, but often Anavex are lacking behind with clinicaltrial.gov updates.
12 weeks I believe because there is an initial observation / baseline period prior the up to 7 weeks dosing.
Anavex Life Sciences Announces First Patient Dosed in Phase 2 Clinical Trial of ANAVEX®2-73 for the Treatment of Rett Syndrome (AVATAR)
The Phase 2 study, AVATAR, is a randomized double-blind, placebo-controlled study to evaluate the safety and efficacy of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Eligible patients with will be randomized to receive once daily oral liquid ANAVEX®2-73 (combined-active group, 18 patients) or placebo (12 patients) for up to 7 weeks (the placebo-controlled period of the trial) including ANAVEX®2-73-specific genomic precision medicine biomarkers. The study will enroll approximately 30 patients aged 18 or higher, and is being run at the Clinical Trials Units of The Alfred and the Royal Melbourne Hospitals in Victoria, Australia. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study is part of an Anavex Rett syndrome program including further studies of ANAVEX®2-73, among them an ongoing Phase 2 study in the US[1].
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