Two Rizatriptan Prescribing Portions for Treatment of Migraine
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Migraine | Drug: rizatriptan | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine |
- Number of Days With Migraine [ Time Frame: 6 months ]
- Number of Migraine Attacks [ Time Frame: 6 months ]
- Percentage of Responders [ Time Frame: 6 months ]Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group
- Average Attack Duration [ Time Frame: 6 months ]
- Headache Severity of All Attacks [ Time Frame: 6 months ]4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)
- Percentage of Attacks With Symptom Elimination at 2 Hours [ Time Frame: 6 months ]Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group
- Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose [ Time Frame: 6 months ]Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group
- Adverse Experiences [ Time Frame: 6 months ]Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.
| Enrollment: | 197 |
| 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 |
|---|---|
|
Active Comparator: Clinical Limit
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.
|
Drug: rizatriptan
10mg ODT 27 tablets
Other Name: Maxalt
|
|
Active Comparator: Formulary Limit
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.
|
Drug: rizatriptan
10mg ODT 9 tablets
Other Name: Maxalt
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patient is at least 18 years of age
- Patient has at least a 1-year history of migraine with or without aura by International Headache Society (IHS) criteria 1.1 and 1.2
- Patient typically has 3-8 migraine attacks/month
- Patient has less than 10 headache days/month with no evidence of IHS 8.2 Medication Overuse Headache
- Patient receives their triptan medication under a pre-determined prescribing allocation ranging from 6-12 tablets per month for the last 3 months preceding Visit 1.
- Patient and investigator agree that multiple doses of rizatriptan described in the package circular are appropriate for non-responsive or recurring headache.
- Patient uses a triptan as mainstay of acute therapy at Visit 1.
- Patient of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of rizatriptan outside the study.
- Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria:
- Patient has headache disorders beyond migraine or episodic tension-type headache IHS 2.1
- Patient is receiving prophylactic therapy for migraine
- Patient is currently taking:
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.
- Patient has basilar or hemiplegic migraine headache.
- Patient has history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or finding consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease.
- Patient has uncontrolled hypertension.
- Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients.
- Patient is pregnant or a nursing mother.
- Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
- Patient has received treatment with an investigational device or compound within 30 days of the study (Visit 1).
- Patient had clinical evidence of significant pulmonary, renal, hepatic, endocrine, neurologic (apart from migraine), psychiatric or any other condition that, in the opinion of the investigator may confound the results of the study, pose an additional risk, or interfere with optimal participation in the study.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00397254
| United States, California | |
| Brian Koffman, MD | |
| Diamond Bar, California, United States, 91765 | |
| San Francisco Clinical Research Center | |
| San Francisco, California, United States, 94109 | |
| 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 |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Roger K. Cady, MD, Clinvest |
| ClinicalTrials.gov Identifier: | NCT00397254 History of Changes |
| Other Study ID Numbers: |
078-00 |
| Study First Received: | November 7, 2006 |
| Results First Received: | March 6, 2009 |
| Last Updated: | June 7, 2010 |
Keywords provided by Clinvest:
|
Migraine rizatriptan |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Rizatriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 18, 2017


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