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Myosin Inhibitor
Mavacamten for Hypertrophic Cardiomyopathy (ODYSSEY-HCM Trial)
Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 weeks
Awards & highlights
ODYSSEY-HCM Trial Summary
This trial is testing a new drug to treat heart problems in people with hypertrophic cardiomyopathy.
Who is the study for?
This trial is for people with a heart condition called non-obstructive hypertrophic cardiomyopathy (nHCM). Participants should have significant thickening of the heart muscle, experience symptoms, and fall under specific classifications of heart function. They can't join if they've had unexplained fainting or dangerous irregular heartbeats recently, or if their condition might be due to another disease.Check my eligibility
What is being tested?
The study is testing Mavacamten against a placebo to see if it's safe and effective for nHCM. Patients will randomly receive either the actual medication or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
While not specified here, common side effects from drugs like Mavacamten may include dizziness, headache, gastrointestinal discomfort, and potential changes in blood pressure or heart rhythm.
ODYSSEY-HCM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 120 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48
Change from baseline in peak oxygen consumption (pVO2) at Week 48
Secondary outcome measures
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48
Change from baseline in cardiac troponin-T (cTn-T) to Week 48
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48
+3 moreODYSSEY-HCM Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MavacamtenExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
2022
Completed Phase 1
~340
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,129,644 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition moderately affects my daily activities.My heart's wall is thicker than normal, or it's slightly less thick but with a family history of HCM.My heart condition mildly or moderately affects my daily activities.I have been diagnosed with HCM with a thickened heart wall.My condition is officially diagnosed as hypertrophic cardiomyopathy.I have had a fast heart rate that lasted more than 30 seconds in the last 6 months.Your heart's blood pressure doesn't increase too much during rest or with physical activity.I have a condition that causes thickening of my heart muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Mavacamten
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being added to this research project?
"Unfortunately, this particular clinical trial is not enrolling patients at the moment. The original posting was on October 31st, 2022 with the most recent update being on October 25th of the same year. Although there are no openings for this study, there are 236 other trials that have open recruitment periods."
Answered by AI
In how many different medical clinics is this research study being conducted today?
"There are a total of 21 sites currently recruiting patients for this trial, which are based in cities including Grand Rapids, London and Kansas City. It would be most convenient to select the clinic nearest you to avoid any unnecessary travel."
Answered by AI
When might Mavacamten be available to the public?
"Mavacamten's safety has been well-documented in Phase 3 trials, with efficacy seen in multiple rounds of testing. As such, it received a score of 3 from our team at Power."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
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