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ANAVEX2-73 liquid

Phase 2

Rett Syndrome | Small molecule | Rare Disease |Anavex Life Sciences Corp.|Last Updated: Aug 21, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment92

FDA Designations

FAST_TRACKORPHAN_DRUGRARE_PEDIATRIC_DISEASE

Clinical trial landscape

ANAVEX2-73 liquid · 1 trial · 1 indication

Phase 2 1
NCT04304482ANAVEX2-73 Study in Pediatric Patients With Rett SyndromeRett Syndrome
COMPLETED92 Analytics
PHASE2COMPLETED
ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome
Rett SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

RSBQ
12 weeks

Change from baseline to End of Treatment (EOT) in the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score

Incidents of Adverse Events
12 weeks

Change from baseline to End of Treatment (EOT)

Secondary Endpoints

CGI-I
12 weeks
Anxiety, Depression, and Mood Scale (ADAMS)
12 weeks
Motor Behavioral Assessment-7 dynamic pediatric items (MBA-Ped7)
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ANAVEX2-73 ActiveEXPERIMENTALANAVEX2-73 liquid oral solution
ANAVEX2-73 PlaceboPLACEBO_COMPARATORPlacebo liquid oral solution

Interventions

NameTypeDescription
ANAVEX2-73 oral liquidDRUGLiquid oral solution
Placebo oral liquidDRUGLiquid oral solution
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Eligibility Criteria

Age Range5 Years to 17 Years
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Aged ≥ 5 years to 17 (inclusive). * Diagnosis of classic RTT, according to 2010 criteria, and a MECP2 mutation. * Post-regression stage, defined as ≥ 6 months since last loss of spoken language or motor (fine or gross) skills. * Clinical Global Impression - Severity (CGI-S) sc...

Countries:AustraliaCanadaUnited Kingdom
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Frequently asked questions about ANAVEX2-73 liquid

What is ANAVEX2-73 liquid used for?

ANAVEX2-73 liquid is an investigational small molecule being developed for the treatment of Rett Syndrome, a rare neurological disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied specifically in pediatric patients with Rett Syndrome.

Who makes ANAVEX2-73 liquid?

ANAVEX2-73 liquid is being developed by Anavex Life Sciences Corp., a biopharmaceutical company. The company's stock is traded under the ticker symbol AVXL. Anavex Life Sciences is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Rett Syndrome.

What phase is ANAVEX2-73 liquid in?

ANAVEX2-73 liquid is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Fast Track designation, Orphan Drug designation, and Rare Pediatric Disease designation by the FDA for the treatment of Rett Syndrome.

What clinical trials is ANAVEX2-73 liquid in?

ANAVEX2-73 liquid has been studied in a Phase 2 clinical trial with the identifier NCT04304482, titled "ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome." This trial was completed and enrolled 92 female participants aged 5 years and older. The study was conducted in Australia, Canada, and the United Kingdom.

Is ANAVEX2-73 liquid FDA approved?

ANAVEX2-73 liquid is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Rett Syndrome. The FDA has granted it Fast Track designation, Orphan Drug designation, and Rare Pediatric Disease designation, which are intended to expedite the development and review of treatments for serious conditions.

How does ANAVEX2-73 liquid work?

ANAVEX2-73 liquid is a small molecule being studied for Rett Syndrome. The specific molecular target of this drug has not been disclosed in available information. Clinical trials are evaluating its safety and efficacy in pediatric patients with Rett Syndrome.