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

Phase 2

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Drug: vafidemstat; Drug: Placebo

• Registration Number: NCT04932291
• Lead Sponsor: Oryzon Genomics S.A.

Brief 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.

Study Timeline

• Study Start: 2021-03-26
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-21
• Status Verified: 2023-09
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-13
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vafidemstat 1.2mg	vafidemstat	Vafidemstat is administered as capsules.
placebo	Placebo	Placebo is administered as capsules.

Primary Outcome Measures

Name	Time	Method
Efficacy: Borderline Personality Disorder Checklist (BPDCL)	From baseline up to week 14	Evaluation of the difference on the Borderline Personality Disorder Checklist (BPDCL), from baseline to specific week, between the active treatment arm and the placebo arm
Efficacy: Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A)	From baseline up to week 14	Evaluation of the difference on the Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A) from baseline to specific week, between the active treatment arm and the placebo arm

Secondary Outcome Measures

Name	Time	Method
Efficacy: Beck Depression Inventory II (BDI-II)	Change up to week 14 and from baseline to week 14	Evaluation of the difference on BDI-II between the active treatment arm and the placebo arm
Efficacy: State-Trait Anxiety Inventory (STAI)	Change up to week 14 and from baseline to week 14	Evaluation of the difference on STAI between the active treatment arm and the placebo arm
Efficacy: Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A)	Change up to week 14	Evaluation of the change over time on the CGI-S A/A
Efficacy: Borderline Evaluation of Severity over Time (BEST)	Change up to week 14 and from baseline to week 14	Evaluation of the difference on BEST between the active treatment arm and the placebo arm
Safety - Adverse events	From baseline to week 14	Treatment emergent adverse events
Efficacy: Borderline Personality Disorder Checklist (BPDCL)	Change up to week 14	Evaluation of the change over time on the BPDCL
Efficacy: State-Trait Anger Expression Inventory 2 (STAXI-2)	Change up to week 14 and from baseline to week 14	Evaluation of the difference on STAXI-2 between the active treatment arm and the placebo arm
Safety - Withdrawn patients	From baseline to week 14	Percentage of withdrawn patients
Safety endpoints - Columbia-Suicide Severity Rating Scale (C-SSRS).	From baseline to week 14	Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial Locations

Locations (21)

DCC "Mladost-M" Ltd, Psychiatr; 🇧🇬 Varna, Bulgaria

Clinical center of Serbia; 🇷🇸 Belgrade, Serbia

Clinical center Kragujevac; 🇷🇸 Kragujevac, Serbia

Excell Research, Inc.; 🇺🇸 Oceanside, California, United States

Revive Research Institute; 🇺🇸 Elgin, Illinois, United States

Center for Emotioal Fitness; 🇺🇸 Cherry Hill, New Jersey, United States

Neurobehavioral Research Inc.; 🇺🇸 Cedarhurst, New York, United States

Core Clinical Research; 🇺🇸 Everett, Washington, United States

Medical Center Hera EOOD - Psychiatry Office; 🇧🇬 Sofia, Sofia-Grad, Bulgaria

Klinik fur Psychiatrie und Psychotherapie, LMU; 🇩🇪 München, Bayern, Germany

Clinic for psychiatric disorders "Laza Lazarevic"; 🇷🇸 Belgrade, Serbia

Emovis GmbH; 🇩🇪 Berlin, Germany

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

The Medical Research Network; 🇺🇸 New York, New York, United States

Excell Research Inc; 🇺🇸 Oceanside, California, United States

Medical Center Intermedika; 🇧🇬 Sofia, Sofia-Grad, Bulgaria

Adams Clinical Trials, LLC; 🇺🇸 Watertown, Massachusetts, United States

New Life Medical Research Center; 🇺🇸 Hialeah, Florida, United States

Phoenix Medical Research LLC; 🇺🇸 Miami, Florida, United States

University of Chicago Institutional Review Board; 🇺🇸 Chicago, Illinois, United States