WHO ICTRP trial

A phase IIb study to evaluate the safety and efficacy of vafidemstat in an adult…

EUCTR2020-003469-20-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2020-003469-20-DE
Public title A phase IIb study to evaluate the safety and efficacy of vafidemstat in an adult borderline personality disorder population
Scientific title 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) - PORTICO
Primary sponsor Oryzon Genomics S.A.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Serbia;Bulgaria;Germany;Spain
Conditions Borderline Personality Disorder (BPD) MedDRA version: 21.1 Level: PT Classification code 10006034 Term: Borderline personality disorder System Organ Class: 10037175 - Psychiatric disorders ;Therapeutic area: Psychiatry and Psychology [F]…
Interventions Product Name: Vafidemstat Product Code: ORY-2001 Pharmaceutical Form: Capsule, hard INN or Proposed INN: VAFIDEMSTAT CAS Number: 1357247-95-0 Other descriptive name: Vafidemstat Concentration unit: mg milligram(s) Concentration type: equal…
Registration date Nov 3, 2021
Target size 188
Secondary IDs CL07-ORY-2001;2020-003469-20-ES
Registry page clinicaltrialsregister.eu

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