24
Participants
Start Date
October 30, 2020
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2023
ES-481
"Treatment Period Week 1 - 25 mg qd, Week 2 - 25 mg bid, Week 3 - 50 mg bid, Week 4 - 75 mg bid.~Step-down and Washout Period Day 1 - 125 mg, Day 2 - 100 mg, Day 3 - 75 mg, Day 4 - 50 mg, Day 5 - 50 mg, Day 6 - 25 mg, Day 7 - 25 mg, Days 8 to 14 - 0 mg"
Placebo
Placebo on Week 1, Week 2, Week 3 and Week 4
Open-Label Extension Study
Dosing will be at the discretion of the Investigator with a minimum dose of 25 mg/day (25 mg qd) to a maximum dose of 150 mg/day (75 mg bid).
RECRUITING
Alfred Health, Melbourne
RECRUITING
Royal Brisbane and Women's Hospital, Herston
RECRUITING
Austin Hospital, Heidelberg
RECRUITING
Royal Melbourne Hospital, Parkville
Lead Sponsor
ES Therapeutics Australia Pty Ltd
INDUSTRY