NCT04304482

ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome

ANAVEX2-73-RS-003 is a Phase 2/3, Double-blind, Randomized, Placebo-controlled Safety and Efficacy Study in Pediatric Patients With RTT

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Anavex Life Sciences Corp. · Industry
• Sex: Female
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

ANAVEX2-73-RS-003 is a Phase 2/3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 5-17 years of age with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.

Detailed description

This Phase 2/3 efficacy study is designed as a double-blind, randomized, placebo-controlled study. This is a 12-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 5-17 years of age. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 48-week open label extension.

Conditions

• Rett Syndrome

Interventions

Type	Name	Description
DRUG	ANAVEX2-73 oral liquid	Liquid oral solution
DRUG	Placebo oral liquid	Liquid oral solution

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-06-01
• Completion: 2023-06-30
• First posted: 2020-03-11
• Last updated: 2023-08-21

Locations

12 sites across 3 countries: Australia, Canada, United Kingdom

Regulatory

• FDA-regulated drug study