Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 09 Apr 2024
Price :
$35
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At a glance
- Drugs Trofinetide (Primary)
- Indications Rett syndrome
- Focus Registrational; Therapeutic Use
- Acronyms LAVENDER
- Sponsors Acadia Pharmaceuticals
- 12 Sep 2023 Results assessing Population Pharmacokinetic Modelling to Confrm Weight-Based Banded Dosing & Exposure-Response Ef- ficacy Analyses to Support Trofnetide Treatment in Rett Syndrome using this study and other 13 studies presented at the 2023 American College of Clinical Pharmacology Annual Meeting
- 12 Sep 2023 Results assessing Population Pharmacokinetic Modelling to Predict Trofnetide Exposure & Exposure-Response Safety Analyses in Girls With Rett Syndrome Aged 2 to 4 Years presented at the 2023 American College of Clinical Pharmacology Annual Meeting
- 13 Jul 2023 According to an Acadia Pharmaceuticals media release, the company intends to submit a New Drug Submission (NDS) for trofinetide in Canada in the next 18 months with plans for Europe, Asia and other regions to be announced at a later date.