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Vafidemstat for Borderline Personality Disorder

Phase 2
Recruiting
Research Sponsored by Oryzon Genomics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women 18-65 years of age.
Are you 18 to 65 years of age?
Timeline
Screening 3 weeks
Treatment 12 weeks
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial is testing whether vafidemstat is effective and safe in treating borderline personality disorder in adults.

Who is the study for?
This trial is for adults aged 18-65 with Borderline Personality Disorder (BPD), confirmed by specific criteria and interviews. Participants should have a BMI between 18.5 and 35, indicating a healthy weight range. Those who've attempted suicide or taken esketamine in the past three months cannot join.Check my eligibility
What is being tested?
The PORTICO study is testing Vafidemstat's effectiveness and safety in treating BPD compared to a placebo. This Phase IIb trial will randomly assign participants to either receive Vafidemstat or an inactive substance, without choosing which one they get.See study design
What are the potential side effects?
While the side effects of Vafidemstat are not detailed here, common side effects in trials may include nausea, headaches, dizziness, fatigue, mood changes or other physical discomforts that vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
Select...
I am between 18 and 65 years old.
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My BMI is between 18.5 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ 12 weeks
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, 12 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Efficacy: Beck Depression Inventory II (BDI-II)
Efficacy: Borderline Evaluation of Severity over Time (BEST)
Efficacy: Borderline Personality Disorder Checklist (BPDCL)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: vafidemstat 1.2mgExperimental Treatment1 Intervention
Vafidemstat is administered as capsules.
Group II: placeboPlacebo Group1 Intervention
Placebo is administered as capsules.

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Oryzon Genomics S.A.Lead Sponsor
4 Previous Clinical Trials
140 Total Patients Enrolled
Michael Ropacki, MDStudy DirectorOryzon Genomics
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04932291 — Phase 2
Borderline Personality Disorder Research Study Groups: vafidemstat 1.2mg, placebo
Borderline Personality Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04932291 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932291 — Phase 2
Borderline Personality Disorder Patient Testimony for trial: Trial Name: NCT04932291 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participation in this clinical trial?

"In accordance with the requirements of this clinical trial, a minimum age requirement of 18 has been set and any participants must be 65 or under."

Answered by AI

How many participants are included in the current clinical trial?

"This clinical trial needs 156 participants who meet the criteria. Oryzon Genomics S.A., is managing this endeavour from a selection of medical sites, such as The Medical Research Network in New york and University of Chicago Institutional Review Board located in Illinois."

Answered by AI

Is this the original trial of its kind?

"Currently, the only trial for vafidemstat is operational across 8 cities and 5 nations. This drug was first tested in 2021 by Oryzon Genomics S.A., with 156 participants in its Phase 2 clinical assessment, which concluded successfully. Since then a total of 18,321 trials have been conducted worldwide."

Answered by AI

What is the prevalence of this trial among clinics in the state?

"Six medical centres are presently hosting this clinical trial, including The Medical Research Network in New york, University of Chicago Institutional Review Board in Chicago and Adams Clinical Trials, LLC in Watertown. Additionally, there are three other participating sites."

Answered by AI

Is it feasible for me to join this research endeavor?

"Those with a diagnosis of borderline personality disorder and aged between 18-65 are eligible to join this clinical trial. The cap for participants is 156 individuals."

Answered by AI

Has vafidemstat been officially sanctioned by the Food and Drug Administration?

"The safety of vafidemstat was rated a 2 as this is only at the Phase 2 level, which implies that there exists some data to support its security but none indicating any efficacy."

Answered by AI

Has any other research delved into the use of vafidemstat?

"In 2021, vafidemstat was trialled for the first time at Care Access-Reify Health. To date, 18,321 trials have been concluded and 1 is still underway; much of this research takes place in New york City."

Answered by AI

Are there available opportunities for individuals to enroll in this research?

"Affirmative. The information on clinicaltrials.gov states that this research, which was initially posted on March 26th 2021, is actively recruiting participants. A total of 156 volunteers must be recruited across 6 different medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
Adams Clinical Trials, LLC
Center for Emotioal Fitness
The Medical Research Network
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
1
3+

Why did patients apply to this trial?

I dont want to die without addressing. I am at a loss on what to do at this point.
PatientReceived 2+ prior treatments
I was diagnosed with borderline personality disorder and need help. I would like to live the next 10-15 years in the best mental health state I can achieve.
PatientReceived 1 prior treatment
There are more research that needs to be done for myself and my Patient group, I must play my part in it.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screening trials take? How long do screenings take and is there any form of compensation?
PatientReceived no prior treatments
Is there any payout for the trial? Also what are the risks I am taking trying this medication?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population
2021. "Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04932291.
All > Borderline Personality Disorder
~39 spots leftby Apr 2025
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