A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine - Full Text View

Sponsors and Collaborators:	Diamond Headache Clinic Merck
Information provided by:	Diamond Headache Clinic
ClinicalTrials.gov Identifier:	NCT00300924

Purpose

The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.

Condition	Intervention	Phase
Migraine	Drug: Rizatriptan co-administered with Acetaminophen	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Acetaminophen Rizatriptan Benzoate Rizatriptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.

Further study details as provided by Diamond Headache Clinic:

Primary Outcome Measures:

To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.

Secondary Outcome Measures:

24 hour sustained pain relief
Pain relief at 30, 45,60,90 minutes and 4 hours post dose
Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
24 sustained pain freedom
Associated symptoms of phonophobia, photophobia, nausea and vomiting
Functional disability
Use of rescue medication
Self-reported adverse experiences

Estimated Enrollment:	200
Study Start Date:	March 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (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:

Subject is at least 18 years of age
Subject has at least a 6 month history of migraine, with or without aura
Subject can distinguish between migraine attacks and other types of headaches
Subject of childbearing potential agrees to use adequate contraception

Exclusion Criteria:

Subject typically has fewer than 1 or greater than 6 migraine attacks per month
Subject typically has greater than 10 headache days per month
Subject has evidence of ischemic heart disease
Subject has uncontrolled high blood pressure
Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

*This list is not all inclusive*

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300924

Locations

United States, California
SanFrancisco Headache Clinic
San Francisco, California, United States, 94109
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Clinvest
Springfield, Missouri, United States
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New York
Elkind Headache Center
Mount Vernon, New York, United States, 10550
United States, Ohio
ClinExcel
West Chester, Ohio, United States, 44121

Sponsors and Collaborators

Diamond Headache Clinic

Merck

Investigators

Study Director:

Merle Diamond, M.D.

Diamond Headache Clinic

More Information

Responsible Party:	Diamond Headache Clinic ( Karin E. Brooks, BSN, RN Director of Clinical Research )
Study ID Numbers:	Merck 075-00, Merk 075-00
Study First Received:	March 9, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00300924
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

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

Brain Diseases
Serotonin
Acetaminophen
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Pharmacologic Actions
Serotonin Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009