Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy

PHASE2UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 30, 2020

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Drug Resistant Epilepsy
Interventions
DRUG

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"

DRUG

Placebo

Placebo on Week 1, Week 2, Week 3 and Week 4

DRUG

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).

Trial Locations (4)

3004

RECRUITING

Alfred Health, Melbourne

Unknown

RECRUITING

Royal Brisbane and Women's Hospital, Herston

RECRUITING

Austin Hospital, Heidelberg

RECRUITING

Royal Melbourne Hospital, Parkville

All Listed Sponsors
lead

ES Therapeutics Australia Pty Ltd

INDUSTRY

NCT04714996 - Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy | Biotech Hunter | Biotech Hunter