Two Rizatriptan Prescribing Portions for Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: rizatriptan; rizatriptan
Intervention description: 10mg ODT 27 tablets; 10mg ODT 9 tablets
Intervention MeSH terms: Rizatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine; rizatriptan

Summary:

      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.
    

Eligibility 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
             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.