Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)(COMPLETED) - Full Text View

Purpose

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.

Condition	Intervention	Phase
Migraine	Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day Drug: Comparator: placebo / Duration of Treatment: 1 day	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Potassium benzoate Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of patients who are pain free at 2 hours postdose.
Tolerability as measured by subjective adverse experience reporting.

Secondary Outcome Measures:

Percentage of patients with 24 hour sustained pain freedom
Percentage of patients free at 30/45/60/90 minutes postdose
Percentage of patients with associated symptoms at 2 hours
Percentage of patients requiring rescue med between 2 & 24 hours
Percentage of patients with functional disability at 2 hours

Estimated Enrollment:	510
Study Start Date:	August 2004
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

6-month history of migraine
Migraine attacks typically mild when they begin with 1-4 migraine attacks per month

Exclusion Criteria:

Heart disease
High blood pressure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092963

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24.

Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. Epub 2007 Nov 13.

Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. Epub 2007 Aug 6.

Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. Epub 2008 Feb 12.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092963 History of Changes
Other Study ID Numbers:	2004_022, MK0462-065
Study First Received:	September 28, 2004
Last Updated:	May 20, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Benzoates
Rizatriptan
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013