Study to Test Rizatriptan in the Early Treatment of Acute Migraine - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00516737

Purpose

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Condition	Intervention	Phase
Migraine	Drug: Comparator: rizatriptan benzoate Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate Potassium benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Participants Who Are Pain Free at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With 24-Hour Sustained Pain Freedom [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
Number of Participants With no Rescue Use up to 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
Number of Participants With Absence of Photophobia at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Number of Participants With Absence of Nausea at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]

Enrollment:	207
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Drug	Drug: Comparator: rizatriptan benzoate Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
2: Placebo Comparator Matching Pbo Comparator	Drug: Comparator: Placebo Matching placebo; one dose, treatment of a single migraine attack

Eligibility

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

Criteria

Inclusion Criteria:

Greater than one year history of migraine
Attacks typically mild when they begin and progress to moderate or severe
Experience 1-4 migraine attacks per month

Exclusion Criteria:

More than 15 headache days per month
Heart disease
Uncontrolled high blood pressure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516737

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_547, MK0462-081
Study First Received:	August 13, 2007
Results First Received:	March 12, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00516737 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Benzoates
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary

Rizatriptan
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on November 22, 2009