Two Rizatriptan Prescribing Portions for Treatment of Migraine - Full Text View

Sponsor:	Clinvest
Collaborator:	Merck
Information provided by:	Clinvest
ClinicalTrials.gov Identifier:	NCT00397254

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: rizatriptan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate

U.S. FDA Resources

Further study details as provided by Clinvest:

Primary Outcome Measures:

Number of Days With Migraine [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Migraine Attacks [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percentage of Responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Average Attack Duration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Headache Severity of All Attacks [ Time Frame: 6 months ] [ Designated as safety issue: No ]
4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)
Percentage of Attacks With Symptom Elimination at 2 Hours [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Adverse Experiences [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.

Enrollment:	197
Study Start Date:	December 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Drug: rizatriptan 10mg ODT 27 tablets Other Name: Maxalt
Active Comparator: 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.	Drug: rizatriptan 10mg ODT 9 tablets Other Name: Maxalt

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397254

Locations

United States, California
Brian Koffman, MD
Diamond Bar, California, United States, 91765
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
United States, Florida
Physician Associates
Oviedo, Florida, United States, 32765
United States, Georgia
Dr. B. Abraham, PC
Snellville, Georgia, United States, 33039
United States, Maryland
Dhiren Shah, MD
Prince Frederick, Maryland, United States, 20678
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Clinvest
Springfield, Missouri, United States, 65807
Mercy Health Research / Ryan Headache Center
St. Louis, Missouri, United States, 63141
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27401
United States, Pennsylvania
Thomas Jefferson University Hospital Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Clinvest

Merck

Investigators

Principal Investigator:

Roger K Cady, MD

Clinvest

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cady RK, Goldstein J, Silberstein S, Juhász 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. Epub 2009 Oct 8.

Responsible Party:	Roger K. Cady, MD, Clinvest
ClinicalTrials.gov Identifier:	NCT00397254 History of Changes
Other Study ID Numbers:	078-00
Study First Received:	November 7, 2006
Results First Received:	March 6, 2009
Last Updated:	June 7, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Clinvest:

Migraine
rizatriptan

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rizatriptan

Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012