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Phase 4 Completed N=155 Randomized Single-blind Treatment

Two Rizatriptan Prescribing Portions for Treatment of Migraine

Source: ClinicalTrials.gov NCT00397254 ↗
Enrolled (actual)
155
Serious AEs
Results posted
Sep 2009
Primary outcomePrimary: Number of Days With Migraine — 2.666; 2.738 Days

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Days With Migraine
2.666; 2.738
SECONDARY
Number of Migraine Attacks
4.855; 4.399
SECONDARY
Percentage of Responders
7.79; 2.70
SECONDARY
Average Attack Duration
11.569; 12.930
SECONDARY
Headache Severity of All Attacks
1.50; 1.59
SECONDARY
Percentage of Attacks With Symptom Elimination at 2 Hours
58.35; 56.60
SECONDARY
Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose
50.74; 48.67
SECONDARY
Adverse Experiences
18; 24

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00397254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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