Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07360405
Eligibility Criteria:
Inclusion Criteria:
* Men and women of all races and ethnicities
* Age 18-75 years
* Documented diagnosis of chronic or episodic migraine for at least 6 months, based on International Classification of Headache Disorders, 3rd edition (ICHD-III) criteria, defined as:
* 8 headache days per month, and
* 4 migraine days per month
* Migraine onset before age 50
* On a stable medication regimen for at least 1 month prior to enrollment
* Willing to maintain stable medications throughout the study
* Willing to discontinue supplements during the study period
* Women of childbearing potential must be willing to use birth control during the study timeframe
Exclusion Criteria:
* Current pregnancy, plans to become pregnant during the study timeframe, or current breastfeeding
* Current use of medications affecting glutamatergic or gamma-Aminobutyric Acid (GABA) neurotransmission (unless discontinued under physician guidance)
* Current use of quarterly injectable migraine preventive medications
* Unwillingness to modify dietary intake or to stop alcohol and marijuana use during the study
* Substance use disorder within the past year
* Diagnosed seizure disorder
* Severe asthma requiring past hospitalization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07360405
Study Brief:
Protocol Section:
NCT07360405