MigrainePhase 2NCT07616128
Study of EVO756 in Adults With Migraine
A Phase 2 study testing EVO756, Dose 1 and EVO756, Dose 2 in people with Migraine, run by Evommune, Inc. at 45 sites in 4 countries.
Trial summary
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine
- What is being tested?
- EVO756, Dose 1 and EVO756, Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 45 sitesin 4 countries
- Study dates
- 29 Jul 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
45 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 4 countries
United States37 sites, 35 recruiting
- Recruiting
Clinosis - Dent Neurologic Instite
Amherst, New York, 14226
EVO756-MIG001 Research Site, 716-250-2017, abryan@dentinstitute.com
- Recruiting
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104
EVO756-MIG001 Research Site, 734-677-6000 ext. 4, research@mhni.com
- Recruiting
Asheville Neurology Specialists, Pa
Asheville, North Carolina, 28806
EVO756-MIG001 Research Site, (828) 210-9306, amberc@ashneuro.com
- Recruiting
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
EVO756-MIG001 Research Site, (678) 705-7341, info@pandaneuro.com
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
EVO756-MIG001 Research Site, (512) 380-9925, ATXClinic@fstrials.com
- Active, not recruiting
Buena Park Research Center
Buena Park, California, 90620
- Recruiting
NeuroScience Research Center
Canton, Ohio, 44718
EVO756-MIG001 Research Site, 330-244-2542, nrc@neurocarecenter.com
- Recruiting
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
EVO756-MIG001 Research Site, 937-424-3033, wbinder@dcndinc.com
- Recruiting
Trialsphere Corp
Chandler, Arizona, 85286
EVO756-MIG001 Research Site, 6232679314, ClinicalResearch@TrialSphereAZ.com
- Recruiting
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
EVO756-MIG001 Research Site, 843-725-5067, Info@clinicaltrialssc.com
- Recruiting
Vaught Neurological Services
Crab Orchard, West Virginia, 25827
EVO756-MIG001 Research Site, 304-252-4222, research@vaughtneurology.com
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
EVO756-MIG001 Research Site, 214-361-7700, dallasleads@fstrials.com
- Recruiting
Accel Research Site-Decatur-Alcanza
Decatur, Georgia, 30030
EVO756-MIG001 Research Site, 404-475-0552, benoit.tete@accelclinical.com
- Recruiting
Denver Neurological Clinic
Denver, Colorado, 80124
EVO756-MIG001 Research Site, 303-715-9024, kmoon@denverneuroclinic.com
- Recruiting
Quest Research Institute-Alcanza
Farmington Hills, Michigan, 48334
EVO756-MIG001 Research Site, 2489578940, Denise.Morgott@questri.com
- Recruiting
Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035
EVO756-MIG001 Research Site, 781-551-5812, info@neurocenterne.com
- Recruiting
Campbell Clinical Research
Franklin, Tennessee, 37067
EVO756-MIG001 Research Site, 615-550-1800, sdawes@ccrsite.com
- Recruiting
Neuro Pain Research Center
Fresno, California, 93710
EVO756-MIG001 Research Site, 5594379700 ext. 316, lflores@neuropain.com
- Recruiting
SFF Medical Research Group LLC
Houston, Texas, 77018
EVO756-MIG001 Research Site, (832) 533-8872, nichole.baio@evommune.com
- Recruiting
Mercury Clinical Research Inc. - Houston Neurology Associates
Houston, Texas, 77478
EVO756-MIG001 Research Site, 7137775343, jmmendez@mercurycr.us.com
- Active, not recruiting
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
- Recruiting
Salma Health La Jolla
La Jolla, California, 92037
EVO756-MIG001 Research Site, 619-902-4328, cyi@salmahealth.com
- Recruiting
CA Medical Clinic for Headache
Los Angeles, California, 90067
EVO756-MIG001 Research Site, (323)879-9999, jlatorre@clinicalri.net
- Recruiting
MedStar Health: Headache Center at McLean
McLean, Virginia, 22101
EVO756-MIG001 Research Site, 202-295-0545, helen.girma@medstar.net
- Recruiting
Apple Medical Research Group, Inc
Miami, Florida, 331216
EVO756-MIG001 Research Site, 3056678434, info@applemedresearch.org
- Recruiting
Blessed Healthcase & Research
Miami, Florida, 33173
EVO756-MIG001 Research Site, 786-491-9998, droman@blessedclinicaltrials.com
- Recruiting
Florida Research Center, Inc.
Miami, Florida, 33174
EVO756-MIG001 Research Site, 7865369009, regulatory@floridarc.net
- Recruiting
Hasbani Neurology
New Haven, Connecticut, 06511
EVO756-MIG001 Research Site, 203-562-8071, jude@neinh.com
- Recruiting
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32819
(407) 425-5100, orlinfo@cnshealthcare.com
- Recruiting
Papillion Research Center - Avacare Clinical Research
Papillion, Nebraska, 68046
EVO756-MIG001 Research Site, 402-282-1502, nicole.linhart@avacare.com
- Recruiting
Eximia Research NC
Raleigh, North Carolina, 27607
EVO756-MIG001 Research Site, (919) 800-5154, achambers@eximiaresearch.com
- Recruiting
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905
EVO756-MIG001 Research Site, 203-914-1903 ext. 142, annelise@neinh.com
- Recruiting
Vantage Clinical Trials
Tampa, Florida, 33614
EVO756-MIG001 Research Site, 8135495265, ysanchez@vantagetrials.com
- Recruiting
Bio Behavoural health
Toms River, New Jersey, 08755
732-244-2299, jryan@bbhnj.com
- Recruiting
Diablo Clinical Research dba Flourish Research
Walnut Creek, California, 94598
EVO756-MIG001 Research Site, 9259307267, kabdullah@flourishresearch.com
- Recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
EVO756-MIG001 Research Site, 5618519400, e.amodie@palmbeachneurology.com
- Recruiting
Mass Institute of Clinical Research
Westborough, Massachusetts, 01581
EVO756-MIG001 Research Site, 9786843011, research@micr.life
New Zealand5 sites, 5 recruiting
- Recruiting
Momentum Clinical Research - Auckland
Auckland, 0622
EVO756-MIG001 Research Site, +64 9 242 3321, Kaylyn.zhang@momcr.co.nz
- Recruiting
Momentum Clinical Research - Christchurch
Christchurch, 8013
EVO756-MIG001 Research Site, +64 3 337 1979, Olivia.rule@momcr.co.nz
- Recruiting
Momentum Clinical Research - Hutt Valley
Upper Hutt, 5018
EVO756-MIG001 Research Site, +64 21 954 630, Sweety.subachandar@lctwellington.co.nz
- Recruiting
Momentum Clinical Research - Kapiti
Waikanae, 5036
EVO756-MIG001 Research Site, +64 04 908 1001, Francois.Lategan@momentumclinicalresearch.co.nz
- Recruiting
Momentum Clinical Research - Wellington
Wellington, 6021
EVO756-MIG001 Research Site, +64 04 801 0002, Kim.Walsh@momentumclinicalresearch.co.nz
Australia2 sites, 2 recruiting
- Recruiting
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
EVO756-MIG001 Research Site, 1300 742 326, westernsydney@paratusclinical.com
- Recruiting
Momentum Clinical Research - Sunshine Melbourne
Saint Albans, Victoria, 3021
EVO756-MIG001 Research Site, 03 9125 0799, Vishwa.patel@momentumclinicalresearch.com.au
Canada1 site, 1 recruiting
- Recruiting
Centre de Recherche St-Louis
Québec, Quebec, G1W 4R4
EVO756-MIG001 Research Site, 1-888-728-9142, info@recherchestlouis.com
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
- Conditions
- Migraine
- Being tested
- EVO756, Dose 1, EVO756, Dose 2, Placebo
- 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
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO756, Dose 1Drug
Orally administered EVO756, Dose 1 (Daily)
EVO756, Dose 2Drug
Orally administered EVO756, Dose 2 (Daily)
PlaceboDrug
Placebo Control (Daily)
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Orally administered EVO756, Dose 1 (Daily) Receives: Drug: EVO756, Dose 1 |
| Dose 2 | Experimental | Orally administered EVO756, Dose 2 (Daily) Receives: Drug: EVO756, Dose 2 |
| Placebo | Placebo comparator | Placebo control (Daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the number of monthly migraine days (MMD)
Measured: Last month of the 12-week treatment period
Secondary outcomes (6)
Mean change from baseline in the number of MMD
Measured: Weeks 4, 8, and across the treatment period (up to 12-weeks)
Mean change from baseline in the number of monthly headache days (MHD)
Measured: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MMD
Measured: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MHD
Measured: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Mean change from baseline in monthly acute migraine medication use days
Measured: 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)
Measured: through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start29 Jul 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evommune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616128
- Sponsor's protocol ID
- EVO756-MIG001
- Status last verified
- Nov 2026
- First submitted
- 19 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults
- ClinicalTrials.gov ID
- NCT07616128
- Acronym / sponsor ID
- EVO756-MIG001
- Conditions
- Migraine
- Keywords
- Migraine Disease, Migraine Disorder, Migraine Disorders, Migraine Headache, Migraine Headaches, Migraine, Migraines, Migraine in Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Evommune, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: EVO756, Dose 1Orally administered EVO756, Dose 1 (Daily) |
| Dose 2 | Experimental | Drug: EVO756, Dose 2Orally administered EVO756, Dose 2 (Daily) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control (Daily) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVO756, Dose 1Orally administered EVO756, Dose 1 (Daily) | Drug | Dose 1 |
| EVO756, Dose 2Orally administered EVO756, Dose 2 (Daily) | Drug | Dose 2 |
| PlaceboPlacebo Control (Daily) | Drug | Placebo |
Primary outcome
Mean change from baseline in the number of monthly migraine days (MMD)
Time frame: Last month of the 12-week treatment period
6 secondary outcomes
Mean change from baseline in the number of MMD
Time frame: Weeks 4, 8, and across the treatment period (up to 12-weeks)
Mean change from baseline in the number of monthly headache days (MHD)
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MMD
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MHD
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Mean change from baseline in monthly acute migraine medication use days
Time frame: 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)
Time frame: through Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVO756, Dose 1 and EVO756, Dose 2 in people with Migraine, run by Evommune, Inc. at 45 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, New Zealand, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nichole Baio ((650) 319-4553, nichole.baio@evommune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the number of monthly migraine days (MMD) (time frame: Last month of the 12-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.