Two Rizatriptan Prescribing Portions for Treatment of Migraine

NCT ID: NCT00397254

Last Updated: 2010-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-01-31

Brief 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.

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clinical Limit

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.

Group Type: ACTIVE_COMPARATOR

rizatriptan

Intervention Type: DRUG

10mg ODT 27 tablets

Formulary Limit

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.

Group Type: ACTIVE_COMPARATOR

rizatriptan

Intervention Type: DRUG

10mg ODT 9 tablets

Interventions

rizatriptan

10mg ODT 27 tablets

Intervention Type: DRUG

rizatriptan

10mg ODT 9 tablets

Intervention Type: DRUG

Other Intervention Names

Maxalt; Maxalt

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Clinvest

OTHER

Sponsor Role: lead

Responsible Party

Clinvest

Principal Investigators

Roger K Cady, MD

Role: PRINCIPAL_INVESTIGATOR

Clinvest

Locations

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

Countries

United States

References

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. doi: 10.1111/j.1526-4610.2004.446006.x.

Reference Type: BACKGROUND

PMID: 15186302 (View on PubMed)

Cady RK, Goldstein J, Silberstein S, Juhasz 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. doi: 10.1111/j.1526-4610.2009.01532.x. Epub 2009 Oct 8.

Reference Type: DERIVED

PMID: 19817885 (View on PubMed)

Other Identifiers

078-00

Identifier Type: -

Identifier Source: org_study_id