A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine … (NCT00894556) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
109 participantsStarted 2009-06-10
Plain-language summary
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
* Patient generally does not respond to treatment with sumatriptan
* Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
* Patient is able to complete paper diary
Exclusion Criteria:
* Patient is pregnant or breast feeding or excepts to become pregnant during the study
* Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
* Patient has basilar or hemiplegic migraines
* Patient is unable to distinguish between migraine attacks from other types of headaches
* Patient has more than 15 headache-days per month
* Patient was greater than 50 years old at age of migraine onset
* Patient has failed to respond to 3 or more triptans
* Patient has a repeated history of failing to respond to or tolerate rizatriptan
* Patient uses opioids as primary migraine therapy
* Patient uses daily opioids
* Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
* Patient has uncontrolled hypertension
* Patient has a history of neoplastic disease
* Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
* Patient has a history of…