Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505650-17-00 | Other Identifier | EU CTR | |
| U1111-1290-1175 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavacamten | Experimental | Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200. |
|
| Placebo | Experimental | Participants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient | At Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in resting LVOT gradient | At Week 28 | |
| Change from baseline in post-exercise peak LVOT gradient | At Week 28 | |
| Change from baseline in maximal wall thickness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0017 | Birmingham | Alabama | 35294-0004 | United States | ||
| Local Institution - 0050 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910394 | Derived | Rossano JW, Canter C, Wolf CM, Papez A, Gambra M, Bryant RM, Alejos J, McCulloch M, Sarquella Brugada G, Bock MJ, Jeewa A, Pearce FB, Desai MY, Favatella N, Javidialsaadi A, Phung V, Rano T, Zhu L, Dyme JL, Mital S; SCOUT-HCM Investigators. Mavacamten in Adolescents with Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2026 Mar 29. doi: 10.1056/NEJMoa2601103. Online ahead of print. | |
| 41038603 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See plan description
See plan description
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Specified dose on specified days |
|
| At Week 28 |
| Change from baseline in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e') | At Week 28 |
| Proportion of participants achieving an increase from baseline to Week 28 in peak oxygen uptake test (pVO2) | From baseline up to Week 28 |
| Proportion of participants achieving a reduction from baseline to Week 28 in maximal LVOT gradient to < 30 mmHg | From baseline up to Week 28 |
| Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) class from baseline to Week 28 | From baseline up to Week 28 |
| Proportion of participants with at least 1 grade improvement in mitral regurgitation at Week 28 | From baseline up to Week 28 |
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to Week 218 |
| Number of participants with treatment-emergent serious adverse events (TESAEs) | Up to Week 218 |
| Change from baseline in electrocardiogram (ECG) (QT interval) | At Week 28 |
| Number of participants with left ventricular ejection fraction (LVEF) ≤ 30% | Up to Week 200 |
| Number of participants with LVEF < 50% | Up to Week 200 |
| Trough observed plasma concentration (Ctrough) | Up to Week 200 |
| Post-dose plasma concentration of mavacamten | Up to Week 200 |
| Maximum observed concentration (Cmax) | Up to Week 200 |
| Area under the concentration-time curve (AUC) | Up to Week 200 |
| Proportion of participants who evaluate taste and swallowability as neutral or better using taste and swallowability scales | At Day 1 and Week 11 |
| Change from baseline in the Hypertrophic Cardiomyopathy Symptom Questionnaire - Shortness of Breath (HCMSQ SoB) domain | At Week 28 |
| Phoenix |
| Arizona |
| 85016-7710 |
| United States |
| Local Institution - 0032 | Los Angeles | California | 90027-6062 | United States |
| Local Institution - 0008 | Los Angeles | California | 90095-8344 | United States |
| Local Institution - 0033 | Palo Alto | California | 94304-1601 | United States |
| Local Institution - 0044 | San Diego | California | 92123-4223 | United States |
| Local Institution - 0038 | Aurora | Colorado | 80045-7106 | United States |
| Local Institution - 0031 | St. Petersburg | Florida | 33701-4634 | United States |
| Local Institution - 0053 | Atlanta | Georgia | 30329-3117 | United States |
| Local Institution - 0013 | Chicago | Illinois | 60637-1447 | United States |
| Local Institution - 0009 | Indianapolis | Indiana | 46202-5272 | United States |
| Local Institution - 0043 | Boston | Massachusetts | 02115-5724 | United States |
| Local Institution - 0002 | Ann Arbor | Michigan | 48109 | United States |
| Local Institution - 0037 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0052 | Morristown | New Jersey | 07960 | United States |
| Local Institution - 0010 | New Hyde Park | New York | 11042 | United States |
| Local Institution - 0024 | New York | New York | 10029-6574 | United States |
| Local Institution - 0036 | New York | New York | 10032-1559 | United States |
| Local Institution - 0040 | The Bronx | New York | 10467-2403 | United States |
| Local Institution - 0015 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 0039 | Durham | North Carolina | 27705 | United States |
| Local Institution - 0019 | Cincinnati | Ohio | 45229 | United States |
| Local Institution - 0001 | Cleveland | Ohio | 44195-0001 | United States |
| Local Institution - 0029 | Columbus | Ohio | 43205 | United States |
| Local Institution - 0030 | Philadelphia | Pennsylvania | 19104-4319 | United States |
| Local Institution - 0005 | Pittsburgh | Pennsylvania | 15224-1334 | United States |
| Local Institution - 0034 | Memphis | Tennessee | 38105 | United States |
| Local Institution - 0045 | Austin | Texas | 78712 | United States |
| Local Institution - 0054 | Houston | Texas | 77030 | United States |
| Local Institution - 0003 | Salt Lake City | Utah | 84113-1103 | United States |
| Local Institution - 0012 | Charlottesville | Virginia | 22908-0816 | United States |
| Local Institution - 0020 | Sydney | New South Wales | 2145 | Australia |
| Local Institution - 0042 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 0041 | Edmonton | Alberta | T6G 2R7 | Canada |
| Local Institution - 0046 | Toronto | Ontario | M5G 1X8 | Canada |
| Local Institution - 0022 | Paris | 75015 | France |
| Local Institution - 0026 | Pessac | 33604 | France |
| Local Institution - 0006 | Munich | Bavaria | 80636 | Germany |
| Local Institution - 0018 | Berlin | State of Berlin | 13353 | Germany |
| Local Institution - 0047 | Dublin 12, D12 N512 | D12 N512 | Ireland |
| Local Institution - 0016 | Florence | FI | 50100 | Italy |
| Local Institution - 0051 | Genova | GE | 16147 | Italy |
| Local Institution - 0027 | Naples | 80131 | Italy |
| Local Institution - 0014 | Barcelona | B | 8950 | Spain |
| Local Institution - 0025 | Madrid | 28046 | Spain |
| Local Institution - 0049 | Belfast | BFS | BT12 6BA | United Kingdom |
| Local Institution - 0007 | London | WC1N 3JH | United Kingdom |
| Derived |
| 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. 2026 Feb;292:107283. doi: 10.1016/j.ahj.2025.107283. Epub 2025 Sep 30. |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605992 | MYK-461 |
Not provided
Not provided
Not provided