The Phase 3 trial for trofinetide, known as the LAVENDER study, conducted by Acadia Pharmaceuticals, began with its first patient enrolled on November 7, 2019, as indicated by the clinical trial registration (NCT04181723). The top-line results were announced on December 6, 2021, according to Acadia’s official press release.
To calculate the total duration from commencement to the announcement of top-line results:
Start Date: November 7, 2019
End Date (Top-line Results Announced): December 6, 2021
This spans from November 7, 2019, to December 6, 2021. Breaking it down:
2019: November 7 to December 31 = 24 days (remaining in November) + 31 days (December) = 55 days
2020: Full year = 366 days (2020 was a leap year)
2021: January 1 to December 6 = 365 days (full year) - 25 days (December 7 to December 31) = 340 days
Total days = 55 (2019) + 366 (2020) + 340 (2021) = 761 days.
Converting 761 days into months (assuming an average of 30.44 days per month, based on a 365-day year divided by 12):
Thus, the total duration of the Phase 3 LAVENDER trial for trofinetide, from commencement to the announcement of top-line results, was approximately 761 days, or roughly 25 months. This includes the enrollment period, the 12-week treatment phase, and the time for data analysis leading to the top-line results announcement.
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