Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Rett Syndrome
Interventions
DRUG

NTI164

Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC, administered orally starting with a dose of 5 mg/kg, titrated up to 20 mg/kg based on tolerance, followed by a maintenance phase at the maximum tolerated dose, and concluding with a gradual dose reduction.

Trial Locations (1)

2145

The Childrens Hospital at Westmead, Sydney

Sponsors
All Listed Sponsors
collaborator

Neurotech International Limited

INDUSTRY

lead

Fenix Innovation Group

INDUSTRY