Study of EVO756 in Adults With Migraine

NCT07616128
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
330
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Lead sponsor
Evommune, Inc.
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Start date
2026-07-29
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Number of sites
20
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Summary
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
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Short title
Study of EVO756 in Adults With Migraine
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Official title
A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-01
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First posted
2026-06-01
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Registry last updated
2026-08-10
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Primary completion date
2027-10-01
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Start date
2026-07-29
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Participants
330
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Participant count basis
Estimated
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Planned participants
330
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Protocol amendments
0
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Number of sites
20
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Evommune, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07616128
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07616128
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Mean change from baseline in the number of monthly migraine days (MMD)

    Timeframe: Last month of the 12-week treatment period

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)