Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03941444 | ANAVEX2-73 Study in Patients With Rett Syndrome | PHASE3 | COMPLETED | 33 | — | — | May 6, 2019 | Sep 30, 2021 | Jan 27, 2022 | 7 | Australia, United Kingdom |
| NCT03758924 | Study of ANAVEX2-73 in Patients With Rett Syndrome | PHASE2 | COMPLETED | 31 | — | — | Feb 28, 2019 | Oct 30, 2020 | Jan 12, 2021 | 8 | United States |
Drug exposure-dependent response of the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score
PK of ANAVEX2-73 and metabolite
PK of ANAVEX2-73 and metabolite
Significant laboratory findings
| Arm | Type | Description |
|---|---|---|
| Active arm | EXPERIMENTAL | ANAVEX2-73 liquid oral solution |
| Placebo arm | PLACEBO_COMPARATOR | Placebo liquid oral solution |
| Name | Type | Description |
|---|---|---|
| ANAVEX2-73 | DRUG | Liquid oral solution |
| Placebo | DRUG | Liquid oral solution |
Inclusion Criteria: * Aged ≥ 18 years, inclusive. * Diagnosis of classic RTT, according to 2010 criteria (Neul et al., 2010), and a MECP2 mutation. * Current pharmacological treatment regimen, including supplements, has been stable for at least 4 weeks. * If on antiepileptic drugs (AEDs), 1-4 AEDs ...