Migraine
Conditions
Keywords
Migraine Disease, Migraine Disorder, Migraine Disorders, Migraine Headache, Migraine Headaches, Migraine, Migraines, Migraine in Adults, Migraine Prophylaxis, Migraine With Aura, Migraine With or Without Aura, Migraine With and Without Aura, Migraine Without Aura, Episodic Migraine Headache, Chronic Migraine Headache
Brief summary
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
Interventions
DRUGEVO756, Dose 1
Orally administered EVO756, Dose 1 (Daily)
DRUGEVO756, Dose 2
Orally administered EVO756, Dose 2 (Daily)
DRUGPlacebo
Placebo Control (Daily)
Sponsors
Evommune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Adults aged 18 to \<65 years * Migraine with or without aura, per ICHD-3 criteria * History of failure with prior preventive migraine treatments * Not currently using migraine preventive therapy Key
Exclusion criteria
* Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders * Use of certain medications * Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in the number of monthly migraine days (MMD) | Last month of the 12-week treatment period |
Secondary
| Measure | 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) |
| 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 |
Countries
United States
Contacts
CONTACTNichole Baio
Outcome results
None listed