Two Rizatriptan Prescribing Portions for Treatment of Migraine

Migraine Clinical Trial

Official title:

An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397254
• Other study ID #: 078-00
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2006
• Last updated: June 7, 2010
• Start date: December 2006
• Est. completion date: January 2008

Study information

• Verified date: September 2009
• Source: Clinvest
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• rizatriptan
10mg ODT 27 tablets
• rizatriptan
10mg ODT 9 tablets

Locations

Country	Name	City	State
United States	Brian Koffman, MD	Diamond Bar	California
United States	PharmQuest	Greensboro	North Carolina
United States	Westside Family Medical Center	Kalamazoo	Michigan
United States	Physician Associates	Oviedo	Florida
United States	Thomas Jefferson University Hospital Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Dhiren Shah, MD	Prince Frederick	Maryland
United States	San Francisco Clinical Research Center	San Francisco	California
United States	Dr. B. Abraham, PC	Snellville	Georgia
United States	Clinvest	Springfield	Missouri
United States	Mercy Health Research / Ryan Headache Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Clinvest	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days With Migraine		6 months	No
Secondary	Number of Migraine Attacks		6 months	No
Secondary	Percentage of Responders	Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group	6 months	No
Secondary	Average Attack Duration		6 months	No
Secondary	Headache Severity of All Attacks	4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)	6 months	No
Secondary	Percentage of Attacks With Symptom Elimination at 2 Hours	Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group	6 months	No
Secondary	Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose	Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group	6 months	No
Secondary	Adverse Experiences	Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.	6 months	Yes