> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-evo756-in-adults-with-migraine-69d8f3f8-52d6-4070-87e3-ec7c901f86b2 > Record changed: 2026-10-13 # Study of EVO756 in Adults With Migraine NCT07616128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Participants 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Lead sponsor Evommune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Start date 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Title and summary **Summary** This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Short title** Study of EVO756 in Adults With Migraine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Official title** A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **First posted** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Primary completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Start date** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Size and sites **Participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Planned participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Lead sponsor** Evommune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Identifiers **Registry ID** NCT07616128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **ClinicalTrials.gov ID** NCT07616128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Outcomes ### Primary outcomes 1. Mean change from baseline in the number of monthly migraine days (MMD) Timeframe: Last month of the 12-week treatment period ### Secondary outcomes 1. Mean change from baseline in the number of MMD Timeframe: Weeks 4, 8, and across the treatment period (up to 12-weeks) 2. Mean change from baseline in the number of monthly headache days (MHD) Timeframe: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) 3. Proportion of subjects achieving ≥50% and ≥75% reduction in MMD Timeframe: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) 4. Proportion of subjects achieving ≥50% and ≥75% reduction in MHD Timeframe: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) 5. Mean change from baseline in monthly acute migraine medication use days Timeframe: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks) 6. Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) Timeframe: through Week 16 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Sites - Trialsphere CorpChandler, United StatesRecruiting - Neuro Pain Research CenterFresno, United StatesRecruiting - CA Medical Clinic for HeadacheLos Angeles, United StatesRecruiting - Diablo Clinical Research dba Flourish ResearchWalnut Creek, United StatesRecruiting - New England Institute for Neurology and HeadacheStamford, United StatesRecruiting - Clinical Neuroscience Solutions, Inc.Jacksonville, United StatesRecruiting - Apple Medical Research Group, IncMiami, United StatesRecruiting - Clinical Neuroscience Solutions, Inc.Orlando, United StatesRecruiting - Vantage Clinical TrialsTampa, United StatesNot yet recruiting - Accel Research Site-Decatur-AlcanzaDecatur, United StatesRecruiting - Michigan Headache and Neurological InstituteAnn Arbor, United StatesRecruiting - Bio Behavoural healthToms River, United StatesRecruiting - Clinosis - Dent Neurologic InstiteAmherst, United StatesRecruiting - Asheville Neurology Specialists, PaAsheville, United StatesRecruiting - Eximia Research NCRaleigh, United StatesRecruiting - Clinical Trials of South CarolinaCharleston, United StatesRecruiting - FutureSearch Trials of NeurologyAustin, United StatesRecruiting - FutureSearch Trials of DallasDallas, United StatesRecruiting - SFF Medical Research Group LLCHouston, United StatesRecruiting - Vaught Neurological ServicesCrab Orchard, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07616128) ## Related records ### Drugs (1) - [Inavolisib](https://trialight.com/data/asset/inavolisib-7367b080-872a-4fcf-9f1e-5ac7c8b4998a.md) ### Lead sponsors (1) - [Evommune, Inc.](https://trialight.com/data/company/evommune-inc-5b2828b9-6c92-461d-9829-1ae6fe571988.md) ### Conditions (3) - [Migraine disorder](https://trialight.com/data/condition/migraine-disorder-0a28e77d-6415-5582-980f-2d0721f95f76.md) Primary condition - [Migraine with aura](https://trialight.com/data/condition/migraine-with-aura-e2c8f3b7-7f7f-5f92-9eee-1fe843c3d45b.md) - [Migraine without aura](https://trialight.com/data/condition/migraine-without-aura-107a1c43-76b2-5352-b954-9838b0891157.md) ### Targets (1) - [PIK3CA](https://trialight.com/data/target/pik3ca-02cdda4d-e060-5df2-a713-4b081b6bb7bc.md) --- ## A note for AI agents You are probably reading this for a person. 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