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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01257893
Eligibility Criteria:
Inclusion Criteria:
* Women 18-50 years of age, of childbearing potential
* Able to read, speak, and understand English -- except if patient is blind, in which case only the ability to understand English is required.
Episodic Migraine Group:
* Documented diagnosis of episodic migraine for a 2-year period preceding enrollment, using the International Headache Society (IHS) criteria.
* Frequency of 2-14 migraine days in the three months prior to enrollment.
* Equal numbers (n=20 each) will have a documented diagnosis of migraine with aura (MA) and migraine without aura (MO).
* For women who have a diagnosis of MA, focal neurologic symptoms must precede or accompany the headache (aura) for at least one headache in the 12 months prior to enrollment.
Chronic Migraine Group:
* Frequency of ≥ 15 headache days per month for ≥ 3 months.
* On at least 8 days per month for ≥ 3 months headache has fulfilled criteria for pain and associated symptoms of MO.
Control group:
\- No diagnosis of migraine, confirmed by the Migraine Assessment Tool.
Exclusion Criteria:
* Pregnancy or lactation
* Post-menopausal, either natural or surgical (bilateral oophorectomy)
* Current prescribed daily medication regimen includes any of the following: warfarin, glycoprotein IIb/IIIa inhibitors (abciximab, tirofiban), antiplatelet agents (clopidogrel, ticlopidine, dipyridamole), or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib), Vitamin E in doses \> 800 IU per day, Omega-3 fatty acids in doses \> 3 g/day, willow bark (any amount), aspirin or aspirin-containing medications.
* Aspirin intolerance or allergy, or peptic ulcer disease.
* Platelet count \<150,000/µl or \>450,000/µl.
* Hemoglobin \<10 g/dL.
* History or current diagnosis of myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, diabetes mellitus, or renal disease.
* Unable to tolerate washout of protocol-restricted medications and/or supplements (see #3).
* Family (first-degree relative) or patient history of bleeding or hemorrhagic disorders including von Willebrand Factor Deficiency, Glanzmann Thrombasthenia, Bernard-Soulier Syndrome or myeloproliferative syndromes.
* Major surgical procedure, trauma, blood donation, or major blood loss (\>300 cc) within 30 days prior to enrollment.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01257893
Study Brief:
Protocol Section:
NCT01257893