Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Two Rizatriptan Prescribing Portions for Treatment of Migraine
This study has been completed.
Sponsors and Collaborators: Clinvest
Merck
Information provided by: Clinvest
ClinicalTrials.gov Identifier: NCT00397254
  Purpose

The primary objective of this study is to evaluate a clinical limit of rizatriptan (9 rizatriptan 10mg ODT per month) vs. a formulary limit 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

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Rizatriptan Benzoate Rizatriptan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title: An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine

Further study details as provided by Clinvest:

Primary Outcome Measures:
  • Number of days with migraine [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of migraine attacks [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Responder rate (50% decrease in attack frequency) [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Average attack duration [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Headache severity of all attacks [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Symptom elimination at 2 hours post-dose for all attacks [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Functional disability at 2 hours post-dose for all attacks [ Time Frame: each month for 6 months ] [ Designated as safety issue: No ]
  • Adverse experiences [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 202
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
Clinical Limit: Active Comparator
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
Formulary Limit: Active Comparator
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

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 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
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
Brian Koffman, MD
Diamond Bar, California, United States, 91765
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:
Responsible Party: Clinvest ( Roger K. Cady, MD )
Study ID Numbers: 078-00
Study First Received: November 7, 2006
Last Updated: March 11, 2008
ClinicalTrials.gov Identifier: NCT00397254  
Health Authority: United States: Institutional Review Board

Keywords provided by Clinvest:
Migraine
rizatriptan

Study placed in the following topic categories:
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009