Amani Therapeutics AM-01-001
About the Study
The purpose of this study is to assess the safety and tolerability of clozapine plus mitiperstat, at three dose levels of mitiperstat, compared to clozapine alone for adults with treatment-resistant schizophrenia.
Eligible participants will be assigned one of four treatments (A, B, C, or D) to receive clozapine co-administered with one of three different doses of mitiperstat (2.5 mg, 5.0 mg, and 7.5 mg), or clozapine alone (without mitiperstat). The starting dose of clozapine will be 12.5 mg in the morning on Day 1 for all treatment groups and the dose will increase, as tolerated. The starting dose of mitiperstat will be 2.5 mg QD
This study is sponsored by Amani Therapeutics.
Eligibility
You may be eligible to participate in this study if you:
are between the ages of 18-65 years old
have a primary diagnosis of schizophrenia based on DSM-5-TR criteria, and confirmed by the MINI assessment
are an appropriate candidate for treatment with clozapine
agree to maintain regular smoking habits throughout the study
If chosen for this study, you will be compensated for every study visit that you complete and we can provide transportation if needed.
If you are interested in participating in this clinical trial, please call our friendly staff at 773-989-8313 ext. 116 today. You can also fill out the contact form below.