Vafidemstat for Borderline Personality Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called vafidemstat for individuals with borderline personality disorder (BPD). Researchers aim to determine if this treatment is safe and effective in managing BPD symptoms compared to a placebo (a pill with no active medicine). The trial seeks adults diagnosed with BPD for at least three months who frequently experience episodes of agitation or aggression. Participants should have a stable living situation and be medically stable, with no recent changes in therapy or medication.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in BPD treatment.
Will I have to stop taking my current medications?
The trial requires that you maintain your current medication regimen throughout the study and not start any new prohibited medications. You should inform your study physician of any changes in your medications during the trial.
Is there any evidence suggesting that vafidemstat is likely to be safe for humans?
Research has shown that vafidemstat is generally safe and well-tolerated. In earlier studies, participants taking vafidemstat did not experience major harmful side effects, indicating the drug did not cause serious health issues. Other studies confirm that vafidemstat can be taken safely and has helped reduce symptoms like agitation and aggression, common in borderline personality disorder. Overall, evidence suggests that vafidemstat is a promising treatment with a good safety record for those considering joining a trial.12345
Why do researchers think this study treatment might be promising for BPD?
Most treatments for Borderline Personality Disorder (BPD) involve psychotherapy and medications like mood stabilizers, antidepressants, and antipsychotics. However, Vafidemstat is unique because it targets a different pathway by inhibiting certain enzymes called histone demethylases. This could help regulate genes involved in emotional regulation and cognitive function, offering a new approach to managing BPD symptoms. Researchers are excited about Vafidemstat because it could potentially address the core emotional dysregulation in BPD more effectively than current options.
What evidence suggests that vafidemstat might be an effective treatment for borderline personality disorder?
Research has shown that vafidemstat, which participants in this trial may receive, offers promising results for treating borderline personality disorder (BPD). One study found that patients taking vafidemstat experienced a significant reduction in symptoms, improving by up to 92.1% compared to those taking a placebo. Other studies have found that vafidemstat helps reduce aggressive behavior and improve mood in people with BPD. Reports indicate it is safe and well tolerated, with no major side effects. These findings suggest vafidemstat could effectively manage BPD symptoms.12367
Who Is on the Research Team?
Michael Ropacki, MD
Principal Investigator
Oryzon Genomics
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vafidemstat or placebo for 14 weeks in a double-blind, randomized, placebo-controlled setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Vafidemstat
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Vafidemstat is administered as capsules.
Placebo is administered as capsules.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oryzon Genomics S.A.
Lead Sponsor
Citations
ORYZON presents the final data from PORTICO, a global ...
The relative reduction in the vafidemstat-treated group over the placebo group reached a maximum of 92.1% at Week 10, with an average reduction ...
A central nervous system basket trial showing safety and ...
The REIMAGINE study supports that vafidemstat is safe, well tolerated, and causes a significant and consistent reduction in agitation/aggression and ...
3.
asebio.com
asebio.com/en/news-events/news/vafidemstat-emerges-promising-treatment-borderline-personality-disorderVafidemstat emerges as a promising treatment for ...
Vafidemstat has shown promise as a potential treatment for BPD in preclinical models and in clinical trials, where it reduced aggressive behavior and improved ...
Vafidemstat: a lysine-specific demethylase 1A inhibitor that ...
It was found that vafidemstat is safe and well tolerated, with no significant drug-induced AEs reported. All the neuropsychiatric scales used showed notable ...
ORYZON Presents the Final Data From PORTICO, a Global ...
The study recruited a total of 211 patients, randomized 1:1 in two arms. The trial had two independent primary endpoints: reduction of agitation ...
6.
oryzon.com
oryzon.com/en/news-events/news/oryzon-presents-blinded-aggregate-safety-data-vafidemstats-ongoing-phase-iibORYZON presents blinded aggregate safety data from ...
ORYZON presents blinded aggregate safety data from vafidemstat's ongoing Phase IIb PORTICO trial in Borderline Personality Disorder. At the ...
A central nervous system basket trial showing safety and ...
The REIMAGINE study supports that vafidemstat is safe, well tolerated, and causes a significant and consistent reduction in agitation/aggression and ...
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