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High dose ANAVEX2-73

Phase 2

Parkinsons Disease With Dementia | Small molecule | Neurology |Anavex Life Sciences Corp.|Last Updated: Oct 22, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment132
FDA Designations
FAST_TRACKORPHAN_DRUGRARE_PEDIATRIC_DISEASE
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03774459ANAVEX2-73 Study in Parkinson's Disease DementiaPHASE2 COMPLETED 132Jul 9, 2018Sep 30, 2020Oct 22, 202025 Australia, Spain
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Study Endpoints
Primary Endpoints
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention
14 weeks

Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
14 weeks

Assess the safety and tolerability of ANAVEX2-73 compared to placebo

Secondary Endpoints
MDS-UPDRS Part III Total Score (Motor Scores)
14 weeks
SDS-CL-25
14 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High dose ANAVEX2-73EXPERIMENTALHigh dose ANAVEX2-73
Mid dose ANAVEX2-73EXPERIMENTALMid dose ANAVEX2-73
Placebo oral capsulePLACEBO_COMPARATORPlacebo oral capsule
Interventions
NameTypeDescription
High dose ANAVEX2-73DRUGActive oral capsule
Mid dose ANAVEX2-73DRUGActive oral capsule
Placebo oral capsuleDRUGPlacebo oral capsule
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of idiopathic Parkinson's disease (PD) consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria. * Diagnosis of probable PD dementia (PDD) according to the Movement Disorder Society Task Force clinical diagnostic criteria. * Montreal Cognitiv...

Countries:AustraliaSpain
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