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ANAVEX2-73 oral liquid for Rett Syndrome (EXCELLENCE Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Anavex Life Sciences Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

EXCELLENCE Trial Summary

This trial is studying a new drug to treat Rett Syndrome. The drug is being tested for safety, tolerability and efficacy in patients 5-17 years old. Multiple clinical and exploratory measures will be used to assess the drug's effectiveness.

Eligible Conditions
  • Rett Syndrome

EXCELLENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidents of Adverse Events
RSBQ
Secondary outcome measures
Anxiety, Depression, and Mood Scale (ADAMS)
CGI-I
Child Health Questionnaire-Parent Form 50 (CHQ-PF50)
+6 more
Other outcome measures
GABA Plasma Concentration
Genetic variant SIGMAR1, COMT
Glutamate Plasma Concentration
+4 more

EXCELLENCE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ANAVEX2-73 ActiveExperimental Treatment1 Intervention
ANAVEX2-73 liquid oral solution
Group II: ANAVEX2-73 PlaceboPlacebo Group1 Intervention
Placebo liquid oral solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANAVEX2-73 oral liquid
2020
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

Anavex Life Sciences Corp.Lead Sponsor
12 Previous Clinical Trials
1,610 Total Patients Enrolled
2 Trials studying Rett Syndrome
64 Patients Enrolled for Rett Syndrome
Anavex Australia Pty Ltd.Industry Sponsor
4 Previous Clinical Trials
1,127 Total Patients Enrolled
Anavex Germany GmbHIndustry Sponsor
4 Previous Clinical Trials
1,223 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is ANAVEX2-73 oral liquid a new medication?

"ANAVEX2-73 is a medication that was first studied in 2019 by MAC Clinical Research. So far, 1 study has been completed with 2 more ongoing. The majority of these clinical trials are based in Vancouver, British Columbia."

Answered by AI

Is this the initial research in this area?

"Research into ANAVEX2-73 oral liquid began in 2019 with a study sponsored by Anavex Germany GmbH. After the initial Phase 1 trial with a sample size of 450, the drug received approval for Phase 2 & 3 trials. Currently, there are 2 active trials being conducted in 5 countries and 32 cities."

Answered by AI

How many people are being enrolled into this clinical trial?

"In total, 84 participants are required for this clinical trial. These individuals must meet the specified inclusion criteria. Patients can participate in this study from locations such as British Columbia Children's Hospital in Vancouver and Alberta Children's Hospital in Calgary."

Answered by AI

Does this research project restrict volunteers to those under 55 years old?

"This particular study is for patients aged 5-17, but there are 382 trials for patients under 18 and 1023 trials for patients over 65."

Answered by AI

Are there different sites where this research is taking place within the state's borders?

"4 hospitals in Canada are recruiting patients for this trial, these include: British Columbia Children's Hospital in Vancouver, Alberta Children's Hospital in Calgary and Holland Bloorview Kids Hospital in Toronto. In addition, there are 4 other locations where recruitment is taking place."

Answered by AI

Are there any unfilled slots in this research project?

"This trial, which was first posted on July 1, 2020, is actively recruiting patients, as indicated on clinicaltrials.gov. The most recent update was on September 4, 2022."

Answered by AI

Are there any restrictions on who is eligible to participate in this clinical trial?

"This clinical trial is looking for 84 participants that currently suffer from Rett Syndrome. The age range for participants is 5-17. In addition to meeting these age requirements, it is also important that patients meet the following criteria: have a Clinical Global Impression - Severity (CGI-S) score of 4 or greater at Screening, have had a stable pharmacological treatment regimen for at least 4 weeks, not electively initiate new or modify ongoing interventions for the duration of the study, be at the post-regression stage, and be aged ≥ 5 years to 17 (inclusive)."

Answered by AI
~19 spots leftby Apr 2025