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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01001234
Eligibility Criteria:
Inclusion Criteria:
* Patient weighs at least 20 kg (44 pounds)
* Patient has had a history of migraine with or without aura \> 6 months with \>= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
* Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
* Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
* Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
* The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and
patient assent
\- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.
Exclusion Criteria:
* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
* Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
* Patient has basilar or hemiplegic migraine headaches
* Patient has \>15 headache-days per month OR has taken medication for acute
headache on more than 10 days per month in any of the 3 months prior to screening
* Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any
cancer, or any other significant disease
* Patient has a history or clinical evidence of cardiovascular problems or stroke
* Patient has either demonstrated hypersensitivity to or experienced a serious
adverse event in response to rizatriptan
* Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
* Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
* Patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
* Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of screening
\- Patient is legally or mentally incapacitated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01001234
Study Brief:
Protocol Section:
NCT01001234