A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
NCT ID: NCT00812006
Last Updated: 2024-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2009-03-24
2009-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
Treatment Sequence A: rizatriptan, rizatriptan, placebo
rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
B
Sequence B: rizatriptan, placebo, rizatriptan
rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
C
Sequence C: placebo, rizatriptan, rizatriptan
rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Interventions
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rizatriptan benzoate
rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack
Comparator: placebo
Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Seeburger JL, Cady RK, Winner P, MacGregor A, Valade D, Ge Y, Zhang Y, Hustad CM, Strickler N, Schaefer E, Connor KM, Ho TW. Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis. Headache. 2012 Jan;52(1):57-67. doi: 10.1111/j.1526-4610.2011.02027.x. Epub 2011 Nov 11.
Other Identifiers
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2008_597
Identifier Type: -
Identifier Source: secondary_id
0462-085
Identifier Type: -
Identifier Source: org_study_id
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