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This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Orally administered EVO756, Dose 1 (Daily) |
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| Dose 2 | Experimental | Orally administered EVO756, Dose 2 (Daily) |
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| Placebo | Placebo Comparator | Placebo control (Daily) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO756, Dose 1 | Drug | Orally administered EVO756, Dose 1 (Daily) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the number of monthly migraine days (MMD) | Last month of the 12-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the number of MMD | Weeks 4, 8, and across the treatment period (up to 12-weeks) | |
| Mean change from baseline in the number of monthly headache days (MHD) | Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nichole Baio | Contact | (650) 319-4553 | nichole.baio@evommune.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CA Medical Clinic for Headache | Not yet recruiting | Los Angeles | California | 90067 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| EVO756, Dose 2 |
| Drug |
Orally administered EVO756, Dose 2 (Daily) |
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| Placebo | Drug | Placebo Control (Daily) |
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| Proportion of subjects achieving ≥50% and ≥75% reduction in MMD | Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) |
| Proportion of subjects achieving ≥50% and ≥75% reduction in MHD | Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) |
| Mean change from baseline in monthly acute migraine medication use days | Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) |
| Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) | through Week 16 |
| New England Institute for Neurology and Headache | Not yet recruiting | Stamford | Connecticut | 06905 | United States |
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| Clinical Neuroscience Solutions, Inc. | Recruiting | Jacksonville | Florida | 32256 | United States |
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| Apple Medical Research Group, Inc | Not yet recruiting | Miami | Florida | 331216 | United States |
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| Clinical Neuroscience Solutions, Inc. | Recruiting | Orlando | Florida | 32819 | United States |
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| Vantage Clinical Trials | Not yet recruiting | Tampa | Florida | 33614 | United States |
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| Accel Research Site-Decatur-Alcanza | Not yet recruiting | Decatur | Georgia | 30030 | United States |
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| Michigan Headache and Neurological Institute | Not yet recruiting | Ann Arbor | Michigan | 48104 | United States |
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| Clinosis - Dent Neurologic Instite | Not yet recruiting | Amherst | New York | 14226 | United States |
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| Eximia Research NC | Recruiting | Raleigh | North Carolina | 27607 | United States |
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| Clinical Trials of South Carolina | Recruiting | Charleston | South Carolina | 29406 | United States |
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| FutureSearch Trials of Neurology | Recruiting | Austin | Texas | 78731 | United States |
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| FutureSearch Trials of Dallas | Recruiting | Dallas | Texas | 75251 | United States |
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| Vaught Neurological Services | Not yet recruiting | Crab Orchard | West Virginia | 25827 | United States |
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| D009422 | Nervous System Diseases |