CompletedPhase 2

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

United States211 participantsStarted 2021-03-26

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Agitation-Aggression Psychiatric Inventory-Clinician Report (AAPI-CR) Agitation \& Aggression (A/A) subscale score of ≥ 16 (severity x frequency) summed across the four (4) items comprising the A/A subscale, and the sum of the A/A subscale severity scores ≥ 6.
✕. Stable living environment for \> 6 months before the Screening visit.
✕. Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
✕. Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
✕. Otherwise, healthy, and medically stable based on medical history.
✕. Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
✕. Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
✕0. Stable in their permitted regimen of background therapy as per drug labeling for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.

Efficacy: Difference in the CGI-S A/A From Baseline to Average of Weeks 8 to 12

Timeframe: From Baseline-Week 0 to average of Weeks 8 to 12

Efficacy: Difference in the BPDCL-Total Score From Baseline to Average of Weeks 8 to 12

Timeframe: From Baseline-Week 0 to average of Weeks 8 to 12

NCT IDNCT04932291

SponsorOryzon Genomics S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-30

Results submitted2024-12-20

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Agitation-Aggression Psychiatric Inventory-Clinician Report (AAPI-CR) Agitation \& Aggression (A/A) subscale score of ≥ 16 (severity x frequency) summed across the four (4) items comprising the A/A subscale, and the sum of the A/A subscale severity scores ≥ 6.
✕. Stable living environment for \> 6 months before the Screening visit.
✕. Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
✕. Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
✕. Otherwise, healthy, and medically stable based on medical history.
✕. Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
✕. Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
✕0. Stable in their permitted regimen of background therapy as per drug labeling for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.