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Sponsors and Collaborators: |
Clinvest Merck |
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Information provided by: | Clinvest |
ClinicalTrials.gov Identifier: | NCT00397254 |
The primary objective of this study is to evaluate a clinical limit of rizatriptan (9 rizatriptan 10mg ODT per month) vs. a formulary limit of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.
Condition | Intervention | Phase |
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Migraine |
Drug: rizatriptan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine |
Enrollment: | 202 |
Study Start Date: | December 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Clinical Limit: Active Comparator
Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg ODT: 27 tablets per month.
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Drug: rizatriptan
10mg ODT 27 tablets
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Formulary Limit: Active Comparator
Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg ODT: 9 tablets per month.
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Drug: rizatriptan
10mg ODT 9 tablets
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A common clinical perception exists that less effective treatment of attacks increases the burden of disease across attacks in the form of increased attack frequency, severity, duration, and/or treatability. If this perception is true, more effective treatment decreases the burden of disease across attacks. There are multiple barriers to effective treatment. The triptan class of migraine medications is frequently dispensed in the context of health benefit plan formulary limitations. Because of limited supply, medications must be used very cautiously. Patients may hoard medication in reaction to fear of running out. Overly cautious use and hoarding may lead to greater disease burden.
The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation ("Formulary Limit") vs. a less limited allocation ("Clinical Limit") on disease burden.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Daily or nearly daily (typically >3 days out of 7 days) use of non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or other analgesics. Aspirin less than or equal to 325mg daily is allowed for cardioprotection.
Monoamine oxidase inhibitors (MAOIs) Propranolol Patient taking either an MAOI ro propranolol may be enrolled in the study, if in the clinical judgement of the investigator, either of these medications can be discontinued 2 weeks prior to study entry. Otherwise the use of MAOIs and propranolol are prohibited during the study.
United States, California | |
San Francisco Clinical Research Center | |
San Francisco, California, United States, 94109 | |
Brian Koffman, MD | |
Diamond Bar, California, United States, 91765 | |
United States, Florida | |
Physician Associates | |
Oviedo, Florida, United States, 32765 | |
United States, Georgia | |
Dr. B. Abraham, PC | |
Snellville, Georgia, United States, 33039 | |
United States, Maryland | |
Dhiren Shah, MD | |
Prince Frederick, Maryland, United States, 20678 | |
United States, Michigan | |
Westside Family Medical Center | |
Kalamazoo, Michigan, United States, 49009 | |
United States, Missouri | |
Clinvest | |
Springfield, Missouri, United States, 65807 | |
Mercy Health Research / Ryan Headache Center | |
St. Louis, Missouri, United States, 63141 | |
United States, North Carolina | |
PharmQuest | |
Greensboro, North Carolina, United States, 27401 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital Jefferson Headache Center | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Roger K Cady, MD | Clinvest |
Responsible Party: | Clinvest ( Roger K. Cady, MD ) |
Study ID Numbers: | 078-00 |
Study First Received: | November 7, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00397254 |
Health Authority: | United States: Institutional Review Board |
Migraine rizatriptan |
Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Rizatriptan Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |