Lack of tyramine pressor response effect with oral CX157: A specific reversible MAOI. This Phase 1, single-center, double-blind, placebo-controlled, three-period study assessed cardiovascular safety of CX157, a specific Reversible Inhibitor of Monoamine Oxidase A (RIMA), following the oral administration of tyramine. In Period 1, the sensitivity of each subject to orally administered tyramine was established by determining the dose of tyramine that elevates SBP ≥30 mmHg on ≥3 consecutive occasions (i.e., TYR303 ). Twelve subjects qualified for randomization in Period 2 during which an oral CX157 Modified Release Tablet (125 mg [N = 10]) or placebo (N = 2) were administered twice per day for 6 days to reach steady state. In Period 3, CX157 and placebo were administered with oral tyramine in fed state
of a putative antidepressant (CX157) versus placebo in depressed subjects with major depressive disorder (MDD) who had had an inadequate response to ongoing antidepressant treatment (NCT00739908). MADRS score changes within one week after randomization directly affected treatment outcome at the study endpoint (week 6). The response and remission rates at week 6 increased significantly as the percent of MADRS score improvement increased between baseline and week 1 regardless of treatment assignment. Less MADRS improvement or actual worsening within the first week after randomization was associated with minimal overall MADRS score changes by week 6 in either treatment assignment. Alternatively, CX157 assigned subjects who had ≥30% improvement by week 1 achieved a significantly greater treatment response
. We applied band-pass filters to re-analyze data from a negative antidepressant trial (NCT00739908) evaluating CX157 (a reversible and selective monoamine oxidase inhibitor-A) versus placebo. 360 patients from 29 trial sites were randomized to either CX157 treatment (n=182) or placebo (n=178). We applied two filters of<3 or>7 points (filter #1) or<3 and>9 points (filter #2) mean change of the total
Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration studies (100).Please remove one or more studies before adding more. Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression (CX157-201) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details
A Study of CX157 (TriRima) for the Treatment of Depression A Study of CX157 (TriRima) for the Treatment of Depression - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration or results information. Search studies before adding more. A Study of CX157 (TriRima) for the Treatment of Depression (CX157-200) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT00739908
Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting studies (100).Please remove one or more studies before adding more. Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers (CX157-112) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details