Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population
Summary
PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.
Timeline
- Start
- 2021-03-26
- Primary completion
- 2023-10-30
- Completion
- 2023-11-13
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Vafidemstat 1.2mg vs Placebo; p = 0.2266; Mean Difference (Final Values) -0.16 (95% CI -0.42 to 0.1) reads as missed primary endpoint NCT04932291 ↗
registry Vafidemstat 1.2mg vs Placebo; p = 0.3839; Median Difference (Final Values) -3.44 (95% CI -11.2 to 4.34) reads as missed primary endpoint NCT04932291 ↗
release “PORTICO trial evaluating vafidemstat as a treatment for Borderline Personality Disorder (BPD). Although the primary endpoints were not met” reads as missed primary endpoint oryzon.com ↗
release “The p-values for the primary endpoints (CGI-S A/A and BPDCL) also improved compared to the preliminary TLD, but did not reach statistical significance.” reads as missed primary endpoint oryzon.com ↗
release “the Phase IIb PORTICO study demonstrated a nominally significant and clinically meaningful reduction of agitation and aggression in the vafidemstat group as compared to placebo” reads as met primary endpoint oryzon.com ↗
release “Vafidemstat showed favorable results over placebo in all primary and secondary efficacy endpoints, as demonstrated by T-Forest plot analysis.” reads as met primary endpoint oryzon.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vafidemstat | Small molecule | 1.2 mg | — |