Clareo Health | A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
