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ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome

NCT04304482 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ANAVEX2-73 oral liquid

Liquid oral solution

DRUG

Placebo oral liquid

Liquid oral solution

Sponsors & Collaborators

  • Anavex Australia Pty Ltd.

    collaborator INDUSTRY

  • Anavex Germany GmbH

    collaborator INDUSTRY

  • Anavex Life Sciences Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-06-01
Completion
2023-06-30
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304482 on ClinicalTrials.gov