Clinical trial NCT00397254: Two Rizatriptan Prescribing Portions for Treatment of Migraine
Official title: An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
rizatriptan
Lead sponsor: Clinvest
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-11-09
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Days With Migraine
timeFrame: 6 months
Secondary outcomes:
measure: Number of Migraine Attacks
timeFrame: 6 months
measure: Percentage of Responders
timeFrame: 6 months
measure: Average Attack Duration
timeFrame: 6 months
measure: Headache Severity of All Attacks
timeFrame: 6 months
measure: Percentage of Attacks With Symptom Elimination at 2 Hours
timeFrame: 6 months
measure: Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose
timeFrame: 6 months
measure: Adverse Experiences
timeFrame: 6 months
Other outcomes:
Locations:
city: Diamond Bar
country: United States
facility: Brian Koffman, MD
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Oviedo
country: United States
facility: Physician Associates
state: Florida
city: Snellville
country: United States
facility: Dr. B. Abraham, PC
state: Georgia
city: Prince Frederick
country: United States
facility: Dhiren Shah, MD
state: Maryland
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research / Ryan Headache Center
state: Missouri
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Clinvest
name: Roger K Cady, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.