Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose 1
Orally administered EVO756, Dose 1 (Daily)
  • Drug: EVO756, Dose 1
    Orally administered EVO756, Dose 1 (Daily)
Experimental
Dose 2
Orally administered EVO756, Dose 2 (Daily)
  • Drug: EVO756, Dose 2
    Orally administered EVO756, Dose 2 (Daily)
Placebo Comparator
Placebo
Placebo control (Daily)
  • Drug: Placebo
    Placebo Control (Daily)

Recruiting Locations

Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256
Contact:
EVO756-MIG001 Research Site
904-281-5757
bsagil@cnshealthcare.com

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32819
Contact:
(650) 319-4553
nichole.baio@evommune.com

Eximia Research NC
Raleigh, North Carolina 27607
Contact:
EVO756-MIG001 Research Site
(919) 800-5154
achambers@eximiaresearch.com

Clinical Trials of South Carolina
Charleston, South Carolina 29406
Contact:
EVO756-MIG001 Research Site
(650) 319-4553
nichole.baio@evommune.com

FutureSearch Trials of Neurology
Austin, Texas 78731
Contact:
EVO756-MIG001 Research Site
(650) 319-4553
nichole.baio@evommune.com

FutureSearch Trials of Dallas
Dallas, Texas 75251
Contact:
EVO756-MIG001 Research Site
(650) 319-4553
nichole.baio@evommune.com

More Details

Status
Recruiting
Sponsor
Evommune, Inc.

Study Contact

Nichole Baio
(650) 319-4553
nichole.baio@evommune.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.