Status:
COMPLETED
A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Lead Sponsor:
Organon and Co
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.
Eligibility Criteria
Inclusion
- Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
- Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
- Patient can distinguish between migraine and other types of headache
- Patient agrees to remain abstinent or use effective birth control during the study
Exclusion
- Patient is pregnant or breast-feeding
- Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
- Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
- Patient was \> 50 years old at age of migraine onset
- Patient has history of heart disease
- Patient has uncontrolled hypertension
- Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
- Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
- Patient is taking more than one other migraine prophylactic medication
- Patient has repeatedly failed to respond to or tolerate rizatriptan
Key Trial Info
Start Date :
March 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00812006
Start Date
March 24 2009
End Date
October 22 2009
Last Update
May 23 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.