Study TRX109013, TREXIMA™ (Sumatriptan + Naproxen Sodium) Versus Butalbital-Containing Combination Medications (BCM) for the Acute Treatment of Migraine - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00599157

Purpose

This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMA will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. (T = TREXIMA; P = placebo; B = butalbital) The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, (4) a Final visit. The Final visit occurs either (A) upon withdrawal, or (B), after treatment of 3 migraine attacks, or C) if the study concludes prior to the subject treating 3 attacks. The primary objective is to evaluate the efficacy of TREXIMA versus BCM for the acute treatment of moderate/severe migraine.

Condition	Intervention	Phase
Migraine	Drug: Trexima Drug: Butalbital-containing Combination Medications (BCM) Drug: butalbital	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Caffeine Headache Migraine

Drug Information available for: Naproxen Naproxen sodium Butalbital Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Subjects with a sustained pain-free (SPF) response from 2-24 hours in subjects using TREXIMA versus those using BCM [ Time Frame: 2-24 hours ]

Secondary Outcome Measures:

Subjects who are pain-free (PF) at 2 hours post-treatment [ Time Frame: 2-48 hours ]
Effects on cognition of treating with BCM vs TREXIMA (as measured by the Mental Efficiency Workload Test (MEWT), measured at 2, 4, 6, 8, 24, and 48 hours [ Time Frame: 2-48 hours ]
Subjects who use rescue medi [ Time Frame: 2-48 hours ]

Estimated Enrollment:	500
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Drug: Trexima Sumatriptan + Naproxen Sodium Drug: Butalbital-containing Combination Medications (BCM) butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) Drug: butalbital butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet])

Detailed Description:

Study TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMA™ (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Study 1 of 2)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 18 to 65 years. If female, using contraception if sexually active and not breastfeeding. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (> 2 months).
Subjects must have an active prescription for a butalbital-containing medication (BCM), must be currently using it as their primary treatment of migraine, and must have used the BCM to treat at least one migraine within the past 30 days.
Subjects must have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in three months prior to screening.
Subjects must be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary (eDiary).
Subject must be able to read English or Spanish and comprehend protocol requirements
Subject is willing and able to provide written informed consent.

Exclusion Criteria:

Subject has >8 migraines or 15 headache days per month in total
Subject has taken >350mg/day of butalbital and/or other barbiturates on average over the 30 days prior to screening.
Subject has a history of heart disease, abdominal perforation or surgery, abdominal ulcer in last 6 months, abdominal bleeding in last 12 months, bowel disease, and any bleeding disorder
Subject has allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbituates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma.
Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a migraine or prophylactic medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
Subject has a recent history of regular use of opioids or barbiturates, other than Butalbital, for the treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months
Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599157

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Hide Study Locations

Locations

United States, Arizona
GSK Investigational Site	Completed
Mesa, Arizona, United States, 85213
GSK Investigational Site	Completed
Gilbert, Arizona, United States, 85234
GSK Investigational Site	Completed
Phoenix, Arizona, United States, 85014
United States, Arkansas
GSK Investigational Site	Completed
Little Rock, Arkansas, United States, 72205
GSK Investigational Site	Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site	Recruiting
Riverside, California, United States, 92501
GSK Investigational Site	Withdrawn
Chino, California, United States, 91710
GSK Investigational Site	Active, not recruiting
Westlake Village, California, United States, 91361
GSK Investigational Site	Recruiting
Sacramento, California, United States, 92585
GSK Investigational Site	Recruiting
Garden Grove, California, United States, 92845
GSK Investigational Site	Recruiting
Newport Beach, California, United States, 92660
GSK Investigational Site	Not yet recruiting
Fresno, California, United States, 93710
GSK Investigational Site	Recruiting
Northridge, California, United States, 91325
GSK Investigational Site	Recruiting
Anaheim, California, United States, 92805
GSK Investigational Site	Recruiting
San Francisco, California, United States, 94109
United States, Connecticut
GSK Investigational Site	Recruiting
East Hartford, Connecticut, United States, 06118-3239
GSK Investigational Site	Recruiting
New Britain, Connecticut, United States, 06050
United States, Florida
GSK Investigational Site	Recruiting
Deland, Florida, United States, 32720
GSK Investigational Site	Completed
Daytona Beach, Florida, United States, 32117
GSK Investigational Site	Withdrawn
Melbourne, Florida, United States, 32901
GSK Investigational Site	Not yet recruiting
Fort Myers, Florida, United States, 33912
United States, Georgia
GSK Investigational Site	Recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
GSK Investigational Site	Recruiting
Maywood, Illinois, United States, 60153
United States, Kentucky
GSK Investigational Site	Withdrawn
Murray, Kentucky, United States, 42071
United States, Louisiana
GSK Investigational Site	Not yet recruiting
Shreveport, Louisiana, United States, 71103
United States, Maine
GSK Investigational Site	Recruiting
Biddeford, Maine, United States, 04005
United States, Massachusetts
GSK Investigational Site	Recruiting
Brockton, Massachusetts, United States, 02301
GSK Investigational Site	Withdrawn
Boston, Massachusetts, United States, 02115
United States, Michigan
GSK Investigational Site	Withdrawn
Bingham Farms, Michigan, United States, 48025
GSK Investigational Site	Recruiting
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
GSK Investigational Site	Withdrawn
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
GSK Investigational Site	Completed
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
GSK Investigational Site	Completed
Springfield, Missouri, United States, 65807
GSK Investigational Site	Recruiting
St. Louis, Missouri, United States, 63141
United States, Nevada
GSK Investigational Site	Withdrawn
Las Vegas, Nevada, United States, 89146
GSK Investigational Site	Completed
Henderson, Nevada, United States, 89014
GSK Investigational Site	Active, not recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
GSK Investigational Site	Withdrawn
Cherry Hill, New Jersey, United States, 08034
United States, New Mexico
GSK Investigational Site	Completed
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site	Completed
New York, New York, United States, 10022
GSK Investigational Site	Recruiting
Schenectady, New York, United States, 12308
GSK Investigational Site	Recruiting
Albany, New York, United States, 12206
United States, North Carolina
GSK Investigational Site	Recruiting
Hickory, North Carolina, United States, 28601
GSK Investigational Site	Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
GSK Investigational Site	Completed
Minot, North Dakota, United States, 58704
GSK Investigational Site	Completed
Fargo, North Dakota, United States, 58104
United States, Ohio
GSK Investigational Site	Recruiting
Cleveland, Ohio, United States, 44122
GSK Investigational Site	Completed
Columbus, Ohio, United States, 43210
GSK Investigational Site	Recruiting
Dayton, Ohio, United States, 45406
GSK Investigational Site	Withdrawn
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
GSK Investigational Site	Recruiting
Greensburg, Pennsylvania, United States, 15601
GSK Investigational Site	Recruiting
Philadelphia, Pennsylvania, United States, 19107-2568
United States, Rhode Island
GSK Investigational Site	Completed
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site	Withdrawn
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site	Completed
Charleston, South Carolina, United States, 29412
GSK Investigational Site	Not yet recruiting
Beaufort, South Carolina, United States, 29902
United States, South Dakota
GSK Investigational Site	Recruiting
Rapid City, South Dakota, United States, 57702
GSK Investigational Site	Withdrawn
Watertown, South Dakota, United States, 57201
United States, Tennessee
GSK Investigational Site	Withdrawn
Memphis, Tennessee, United States, 38018
GSK Investigational Site	Recruiting
Germantown, Tennessee, United States, 38139
United States, Texas
GSK Investigational Site	Withdrawn
Katy, Texas, United States, 77450
GSK Investigational Site	Recruiting
San Antonio, Texas, United States, 78258
GSK Investigational Site	Recruiting
Houston, Texas, United States, 77004
GSK Investigational Site	Withdrawn
Dallas, Texas, United States, 75214
GSK Investigational Site	Recruiting
Austin, Texas, United States, 78745
GSK Investigational Site	Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site	Withdrawn
Alexandria, Virginia, United States, 22311
GSK Investigational Site	Withdrawn
Alexandria, Virginia, United States, 22304
GSK Investigational Site	Recruiting
Virginia Beach, Virginia, United States, 23452
GSK Investigational Site	Withdrawn
Roanoke, Virginia, United States, 24013
United States, Washington
GSK Investigational Site	Withdrawn
Wenatchee, Washington, United States, 98801
United States, West Virginia
GSK Investigational Site	Withdrawn
Charleston, West Virginia, United States, 25301
Puerto Rico
GSK Investigational Site	Withdrawn
San Juan, Puerto Rico, 00918

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Pharm D

GlaxoSmithKline

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRX109013
Study First Received:	January 10, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00599157 History of Changes
Health Authority:	United States: Food and Drug Administration