Two Rizatriptan Prescribing Portions for Treatment of Migraine

Completed · Phase 4

Conditions studied: Migraine

In brief

The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.

Key facts

Study ID

NCT00397254

Run by

Clinvest

People needed

197

Starts

2006-12-01

Expected to finish

2008-01-01

Last updated by the study team

2010-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brian Koffman, MD — Diamond Bar, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Physician Associates — Oviedo, Florida, United States
• Dr. B. Abraham, PC — Snellville, Georgia, United States
• Dhiren Shah, MD — Prince Frederick, Maryland, United States
• Westside Family Medical Center — Kalamazoo, Michigan, United States
• Clinvest — Springfield, Missouri, United States
• Mercy Health Research / Ryan Headache Center — St Louis, Missouri, United States
• PharmQuest — Greensboro, North Carolina, United States
• Thomas Jefferson University Hospital Jefferson Headache Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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