Anavex Life Sciences Corp (AVXL)

[georgejjl]

ANAVEX2-73 Study in Patients With Rett Syndrome (AVATAR)
ANAVEX2-73-RS-002 is a Phase 3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 18 years and older with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.


Primary Outcome Measures :
RSBQ [ Time Frame: 7 weeks ]
Drug exposure-dependent response of the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score

Incidence of Adverse Events [ Time Frame: 7 weeks ]
Incidence of Adverse Events


Secondary Outcome Measures :
CGI-I [ Time Frame: 7 weeks ]
Drug exposure-dependent response of the Clinical Global Impression of Improvement Scale (CGI-I) score

Anxiety, Depression, and Mood Scale (ADAMS) [ Time Frame: 7 weeks ]
Drug exposure-dependent response of the Anxiety, Depression, and Mood Scale (ADAMS)

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


Other Outcome Measures:
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

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

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

Good luck and GOD bless,