Status:
COMPLETED
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Lead Sponsor:
Organon and Co
Conditions:
Acute Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.
Eligibility Criteria
Inclusion
- 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
- 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 drug or alcohol abuse
Key Trial Info
Start Date :
June 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2010
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00894556
Start Date
June 10 2009
End Date
January 12 2010
Last Update
May 10 2024
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