Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANAVEX2-73 · 5 trials · 3 indications
Drug exposure-dependent response of the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score
To continue assessing the safety and tolerability of ANAVEX2-73
PK of ANAVEX2-73 and metabolite
PK of ANAVEX2-73 and metabolite
Significant laboratory findings
Safety
| Arm | Type | Description |
|---|---|---|
| Active arm | EXPERIMENTAL | ANAVEX2-73 liquid oral solution |
| Placebo arm | PLACEBO_COMPARATOR | Placebo liquid oral solution |
| ANAVEX2-73 Active | EXPERIMENTAL | Oral capsules |
| ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 | EXPERIMENTAL | - |
| Anavex2-73 oral then the Anavex2-73 intravenous formulation | EXPERIMENTAL | Participants first receive Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. After a washout period of 11 days they then receive the Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. |
| Anavex2-73 intravenous then the Anavex2-73 oral formulation | EXPERIMENTAL | Participants first receive Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. After a washout period of 11 days then they receive the Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. |
| Anavex2-73 30 mg oral formulation | EXPERIMENTAL | Participants will receive the 30 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks. |
| Anavex2-73 50 mg oral formulation | EXPERIMENTAL | Participants will receive the 50 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| ANAVEX2-73 | DRUG | Liquid oral solution |
| Placebo | DRUG | Liquid oral solution |
| ANAVEX2-73 Oral | DRUG | - |
| ANAVEX2-73 Intravenous | DRUG | - |
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 ...