• Number of Migraine Attacks (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Percentage of Responders (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Average Attack Duration (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Headache Severity of All Attacks (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Percentage of Attacks Wtih Symptom Elimination at 2 Hours (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Adverse Experiences (Formulary Limit Group Versus Clinical Limit Group) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

• Number of migraine attacks per month
• Responder rate (50% decrease in attack frequency)
• Average attack duration
• Headache severity
• Symptom elimination at 2 hours post-dose
• Functional disability at 2 hours post-dose
• Adverse experiences

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.

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.

• 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.
• 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.

• 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.
• Cady RK, Goldstein J, Silberstein S, Juhász M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. Epub 2009 Oct 8.

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.