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A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents - NCT01001234-75230(Clinical Trial 443419)



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City:  Dallas
State:  
TX
Zip Code: 75230
Conditions: Acute Migraine With or Without Aura in Children and Adolescents.
Purpose: To provide efficacy data for Rizatriptan in children and adolescents.
Study summary:
Criteria: Inclusion Criteria: - Patient is between 6 and 17 years of age inclusive at screening Visit 1 - 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 NSAIDs or 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, 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 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, 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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