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Recruiting

NCT Number: NCT07616128

Study of EVO756 in Adults With Migraine

This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.

Recruiting

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine with Aura Migraine without Aura Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CA Medical Clinic for Headache, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVO756, Dose 1

Drug

Orally administered EVO756, Dose 1 (Daily)

EVO756, Dose 2

Drug

Orally administered EVO756, Dose 2 (Daily)

Placebo

Drug

Placebo Control (Daily)

Primary outcomes

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

    Time frame: Last month of the 12-week treatment period

Secondary outcomes

  1. Mean change from baseline in the number of MMD

    Time frame: 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)

    Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)

  3. 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)

  4. 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)

  5. 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)

  6. Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

    Time frame: through Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Nichole Baio

CONTACT

[email protected]

(650) 319-4553

Sponsors and collaborators

Lead sponsor

Evommune, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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