Anavex Life Sciences Corp (AVXL)

[sokol]

Which outcome measures may have been missed?

Avatar primary and secondary outcomes:

https://clinicaltrials.gov/ct2/show/NCT03941444

Primary Outcome Measures :
Incidence of Adverse Events [ Time Frame: 7 weeks ]
Incidence of Adverse Events

Maximum Plasma Concentration [Cmax] of ANAVEX2-73 [ Time Frame: 7 weeks ]
PK of ANAVEX2-73 and metabolite

Area Under the Curve [AUC] of ANAVEX2-73 [ Time Frame: 7 weeks ]
PK of ANAVEX2-73 and metabolite

Lipid panel [ Time Frame: 7 weeks ]
Significant laboratory findings


Secondary Outcome Measures :
RSBQ [ Time Frame: 7 weeks ]
Change from baseline to End of Treatment (EOT) in the Rett Syndrome Behaviour Questionnaire (RSBQ)

CGI-I [ Time Frame: 7 weeks ]
Change from baseline to End of Treatment (EOT) in the Clinical Global Impression Improvement Scale (CGI-I) score


Other Outcome Measures:
Anxiety, Depression, and Mood Scale (ADAMS) [ Time Frame: 7 weeks ]
Anxiety, Depression, and Mood Scale (ADAMS)

Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: 7 weeks ]
Children's Sleep Habits Questionnaire (CSHQ)

Seizure Frequency via seizure diary [ Time Frame: 7 weeks ]
Seizure Frequency via seizure diary

Genetic variant SIGMAR1, COMT [ Time Frame: 7 weeks ]
Genetic variant SIGMAR1, COMT

Glutamate Plasma Concentration [ Time Frame: 7 weeks ]
Glutamate Plasma Concentration

GABA Plasma Concentration [ Time Frame: 7 weeks ]
GABA Plasma Concentration

From slide 29 - January 2022 publication posted on Seeking Alpha January 11, 2022:
Primary and Secondary Endpoints
RSBQ, CGI-l
ADAMS, Sleep function
Seizure activity
Safety and tolerability of
ANAVEX®2-73
Glutamate biomarker

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