Study of EVO756 in Adults With Migraine
A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults
1 other identifier
interventional
330
1 country
14
Brief Summary
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2026
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
July 1, 2026
June 1, 2026
1.3 years
May 19, 2026
June 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in the number of monthly migraine days (MMD)
Last month of the 12-week treatment period
Secondary Outcomes (6)
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)
- +1 more secondary outcomes
Study Arms (3)
Dose 1
EXPERIMENTALOrally administered EVO756, Dose 1 (Daily)
Dose 2
EXPERIMENTALOrally administered EVO756, Dose 2 (Daily)
Placebo
PLACEBO COMPARATORPlacebo control (Daily)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evommune, Inc.lead
Study Sites (14)
CA Medical Clinic for Headache
Los Angeles, California, 90067, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Apple Medical Research Group, Inc
Miami, Florida, 331216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32819, United States
Vantage Clinical Trials
Tampa, Florida, 33614, United States
Accel Research Site-Decatur-Alcanza
Decatur, Georgia, 30030, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinosis - Dent Neurologic Instite
Amherst, New York, 14226, United States
Eximia Research NC
Raleigh, North Carolina, 27607, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
Vaught Neurological Services
Crab Orchard, West Virginia, 25827, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2026
First Posted
June 1, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share