NCT03941444

ANAVEX2-73 Study in Patients With Rett Syndrome

A Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients With Rett Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Anavex Life Sciences Corp. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

ANAVEX2-73-RS-002 is a Phase 3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 18 years and older with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.

Detailed description

This Phase 3 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study. This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients to continue a 48-week open label extension.

Conditions

• Rett Syndrome

Interventions

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

Timeline

• Start date: 2019-05-06
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-05-08
• Last updated: 2022-01-27

Locations

7 sites across 2 countries: Australia, United Kingdom