A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT ID: NCT06253221

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2031-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiomyopathy, Hypertrophic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HCM mavacamten Obstructive Hypertrophic Cardiomyopathy SCOUT SCOUT-HCM Pediatric HCM Pediatric hypertrophic cardiomyopathy Symptomatic HCM oHCM

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mavacamten

Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Placebo

Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mavacamten

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-986427

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of HCM
* Presence of LVOT obstruction
* Presence of symptoms

Exclusion Criteria

* Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
* Evidence of LVEF \<50% in prior 6 months
* Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0017

Birmingham, Alabama, United States

Site Status

Local Institution - 0050

Phoenix, Arizona, United States

Site Status

Local Institution - 0032

Los Angeles, California, United States

Site Status

Local Institution - 0008

Los Angeles, California, United States

Site Status

Local Institution - 0033

Palo Alto, California, United States

Site Status

Local Institution - 0044

San Diego, California, United States

Site Status

Local Institution - 0038

Aurora, Colorado, United States

Site Status

Local Institution - 0031

St. Petersburg, Florida, United States

Site Status

Local Institution - 0053

Atlanta, Georgia, United States

Site Status

Local Institution - 0013

Chicago, Illinois, United States

Site Status

Local Institution - 0009

Indianapolis, Indiana, United States

Site Status

Local Institution - 0043

Boston, Massachusetts, United States

Site Status

Local Institution - 0002

Ann Arbor, Michigan, United States

Site Status

Local Institution - 0037

St Louis, Missouri, United States

Site Status

Local Institution - 0052

Morristown, New Jersey, United States

Site Status

Local Institution - 0010

New Hyde Park, New York, United States

Site Status

Local Institution - 0024

New York, New York, United States

Site Status

Local Institution - 0036

New York, New York, United States

Site Status

Local Institution - 0040

The Bronx, New York, United States

Site Status

Local Institution - 0015

Charlotte, North Carolina, United States

Site Status

Local Institution - 0039

Durham, North Carolina, United States

Site Status

Local Institution - 0019

Cincinnati, Ohio, United States

Site Status

Local Institution - 0001

Cleveland, Ohio, United States

Site Status

Local Institution - 0029

Columbus, Ohio, United States

Site Status

Local Institution - 0030

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0005

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0034

Memphis, Tennessee, United States

Site Status

Local Institution - 0045

Austin, Texas, United States

Site Status

Local Institution - 0054

Houston, Texas, United States

Site Status

Local Institution - 0003

Salt Lake City, Utah, United States

Site Status

Local Institution - 0012

Charlottesville, Virginia, United States

Site Status

Local Institution - 0020

Sydney, New South Wales, Australia

Site Status

Local Institution - 0042

Clayton, Victoria, Australia

Site Status

Local Institution - 0041

Edmonton, Alberta, Canada

Site Status

Local Institution - 0046

Toronto, Ontario, Canada

Site Status

Local Institution - 0022

Paris, , France

Site Status

Local Institution - 0026

Pessac, , France

Site Status

Local Institution - 0006

Munich, Bavaria, Germany

Site Status

Local Institution - 0018

Berlin, State of Berlin, Germany

Site Status

Local Institution - 0047

Dublin 12, D12 N512, , Ireland

Site Status

Local Institution - 0016

Florence, FI, Italy

Site Status

Local Institution - 0051

Genova, GE, Italy

Site Status

Local Institution - 0027

Napoli, , Italy

Site Status

Local Institution - 0014

Barcelona, B, Spain

Site Status

Local Institution - 0025

Madrid, , Spain

Site Status

Local Institution - 0049

Belfast, BFS, United Kingdom

Site Status

Local Institution - 0007

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada France Germany Ireland Italy Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Rossano J, Canter C, Wolf C, Favatella N, Lockman J, Puli S, Javidialsaadi A, Dyme J, Crevar C, Mital S. Mavacamten in symptomatic adolescent patients with obstructive hypertrophic cardiomyopathy: design of the phase 3 SCOUT-HCM trial. Am Heart J. 2025 Sep 30;292:107283. doi: 10.1016/j.ahj.2025.107283. Online ahead of print.

Reference Type DERIVED
PMID: 41038603 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-505650-17-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1290-1175

Identifier Type: OTHER

Identifier Source: secondary_id

CV027-010

Identifier Type: -

Identifier Source: org_study_id