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:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01481103
Eligibility Criteria:
Inclusion Criteria:
* Migraine with or without aura according to the International Headache Society classification and diagnosed by a Medical Doctor.
* Subjects are required to have between 2 and 12 migraines but no more than 15 headache days (migraine or nonmigraine) per 28 days during the prospective baseline phase. A headache day is defined as a calendar day during which the patient experienced headache for at least 30 minutes.
* Taking a nonprescription medication for the migraine pain. More specifically Aspirin, Ibuprofen, Naproxen, and/or Acetaminophen (with or without caffeine).
* Age between 18 and 65 years.
* A history of migraine for at least 12 months.
* Completed at least 75% of the baseline headache diary.
* Completion of written informed consent.
Exclusion Criteria:
* Onset of headache disorder less than 12 months prior to age 50.
* Pregnancy or planning to get pregnant while participating in the study.
* Malignancy; cluster headache (IHS code 3); sinus headaches.
* Suspicion that headache disorder has specific etiology (IHS code 5-11); cranial neuralgias (IHS code12)
* Acupuncture treatment in the previous 12 months.
* Taking a prescription medication for the migraine pain.
* Subject plans to receive acupuncture for another medical condition while participating in the study.
* Systemic disorder or illness, including serious psychiatric illness.
* Failure to fulfill baseline information.
* Failure to provide written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01481103
Study Brief:
Protocol Section:
NCT01481103