NCT04932291

Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population

"A Double-blind, Randomized, Placebo-controlled, Adaptive 14-week Phase IIb Trial to Evaluate the Efficacy and Safety of Vafidemstat in an Adult Borderline Personality Disorder (BPD) Population (PORTICO)"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Oryzon Genomics S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

Detailed description

PORTICO is a double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population.

Conditions

• Borderline Personality Disorder

Interventions

Type	Name	Description
DRUG	vafidemstat	1.2mg capsule
DRUG	Placebo	placebo capsule

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-10-30
• Completion: 2023-11-13
• First posted: 2021-06-21
• Last updated: 2023-11-28

Locations

21 sites across 5 countries: United States, Bulgaria, Germany, Serbia, Spain

Regulatory

• FDA-regulated drug study