A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents - NCT01001234-10550 (Clinical Trial 462101)
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| City: |
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Mount Vernon |
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State:
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NY |
| Zip Code: |
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10550 |
| Conditions: |
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Acute Migraine With or Without Aura in Children and Adolescents. |
| Purpose: |
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To provide efficacy data for Rizatriptan in children and adolescents.
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| Study summary: |
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| Criteria: |
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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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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