A Study of ANAVEX3-71 in Adults With Schizophrenia
← catalyst calendarSponsored by Anavex Life Sciences Corp. (industry) · AVXL — their whole pipeline →. With COGNISION, Cognitive Research Corporation, Hassman Research Institute.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
71actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-15 | actual | When the study began enrolling |
| Primary completion | 2025-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Schizophrenia
Interventions
- Drug: ANAVEX3-71 oral capsules
- Drug: Placebo oral capsules
Primary outcomes
what the primary-completion date above is the date OFSingle Dose Maximum Observed Plasma Concentration (Cmax)
measured Part A: Day 1
Multiple Dose Maximum Observed Plasma Concentration (Cmax)
measured Part A: Day 1 and Day 9
Cmax (steady state)
measured Part A: Day 1 and Day 9
Tmax (steady state)
measured Part A: Day 1 and Day 9
AUC (steady state)
measured Part A: Day 1 and Day 9
AUC (single state)
measured Part A: Day 1 and Day 9
CL/F (steady state)
measured Part A: Day 1 and Day 9
Vz/F (steady state)
measured Part A: Day 1 and Day 9
T1/2 (steady state)
measured Part A: Day 1 and Day 9
Rac (steady state)
measured Part A: Day 1 and Day 9
Rac, Cmax (steady state)
measured Part A: Day 1 and Day 9
PTR (steady state)
measured Part A: Day 1 and Day 9
Adverse Events
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Vital Signs
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (RR interval)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (P wave)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (PR interval)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (PR segment)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (QRS complex)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (ST segment)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (T wave)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (QT interval)
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Renal Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Hepatic Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Lipid Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Hematology Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Urinalysis Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Coagulation Panel
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Brief Physical Examination
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Brief Neurological Examination
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
AIMS
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
SAS
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
BARS
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
CDSS
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
C-SSRS
measured Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
EEG-ERP - Passive, Duration Deviant, Oddball ERP
measured Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Active, Auditory, Oddball ERP
measured Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Auditory Steady State Response
measured Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Resting EEG
measured Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
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