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Clinical trial of vafidemstat in patients with schizophrenia
THE MAIN OBJECTIVE OF THE STUDY IS TO INVESTIGATE WHETHER THE STUDY MEDICATION (VAFIDEMSTAT) WORKS IN THE TREATMENT OF THE NEGATIVE SYMPTOMS OF THE DISEASE, DESCRIBED ABOVE, AS WELL AS IN THE TREATMENT OF THE LOSS OF COGNITIVE FUNCTION IN PATIENTS WITH SCHIZOPHRENIA, AND ALSO WHETHER THIS MEDICATION IS SAFE. THE STUDY ALSO AIMS TO LEARN MORE ABOUT THE CAUSES OF THE DISEASE AND HOW OUR BODY PROCESSES THE STUDY MEDICATION. IT IS KNOWN THAT THERE IS A GENETIC VARIABILITY IN THE POPULATION (WHICH IS NOT ASSOCIATED WITH ANY DISEASE) THAT DETERMINES CERTAIN DIFFERENCES IN THE ABSORPTION, DISTRIBUTION, METABOLISM AND ELIMINATION OF DRUGS AND THUS AFFECTS THE BLOOD LEVELS OF THE DRUG.
- PHASE IIB, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE, 24-WEEK, PHASE IIB STUDY TO EVALUATE THE EFFICACY OF VAFIDEMSTAT ON NEGATIVE SYMPTOMS AND COGNITIVE IMPAIRMENT ASSOCIATED WITH SCHIZOPHRENIA.
- Code EudraCT: 2021-000350-26
- Protocol number: CL09-ORY-2001
- Promoter: Oryzon Genomics
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