Two Rizatriptan Prescribing Portions for Treatment of Migraine

Condition(s) targeted: Migraine

Intervention: rizatriptan (Drug); rizatriptan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Clinvest

Official(s) and/or principal investigator(s):
Roger K Cady, MD, Principal Investigator, Affiliation: Clinvest

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.

Official title: An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Number of days with migraine

Secondary outcome:

Number of migraine attacks

Responder rate (50% decrease in attack frequency)

Average attack duration

Headache severity of all attacks

Symptom elimination at 2 hours post-dose for all attacks

Functional disability at 2 hours post-dose for all attacks

Adverse experiences

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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.

San Francisco Clinical Research Center, San Francisco, California 94109, United States

Brian Koffman, MD, Diamond Bar, California 91765, United States

Physician Associates, Oviedo, Florida 32765, United States

Dr. B. Abraham, PC, Snellville, Georgia 33039, United States

Dhiren Shah, MD, Prince Frederick, Maryland 20678, United States

Westside Family Medical Center, Kalamazoo, Michigan 49009, United States

Clinvest, Springfield, Missouri 65807, United States

Mercy Health Research / Ryan Headache Center, St. Louis, Missouri 63141, United States

PharmQuest, Greensboro, North Carolina 27401, United States

Thomas Jefferson University Hospital Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States

Related publications:

Brandes JL, Visser WH, Farmer MV, Schuhl AL, Malbecq W, Vrijens F, Lines CR, Reines SA; Protocol 125 study group. Montelukast for migraine prophylaxis: a randomized, double-blind, placebo-controlled study. Headache. 2004 Jun;44(6):581-6.

Starting date: December 2006
Ending date: January 2008
Last updated: March 11, 2008