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

Condition(s) targeted: Migraine

Intervention: Trexima (Drug); Butalbital-containing Combination Medications (BCM) (Drug); butalbital (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Pharm D, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

Official title: See Detailed Description

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Primary outcome: Subjects with a sustained pain-free (SPF) response from 2-24 hours in subjects using TREXIMA versus those using BCM

Secondary outcome:

Subjects who are pain-free (PF) at 2 hours post-treatment

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

Subjects who use rescue medi

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)

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, San Juan 00918, Puerto Rico; Withdrawn

GSK Investigational Site, Mesa, Arizona 85213, United States; Completed

GSK Investigational Site, Gilbert, Arizona 85234, United States; Completed

GSK Investigational Site, Phoenix, Arizona 85014, United States; Completed

GSK Investigational Site, Little Rock, Arkansas 72205, United States; Completed

GSK Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

GSK Investigational Site, Riverside, California 92501, United States; Recruiting

GSK Investigational Site, Chino, California 91710, United States; Withdrawn

GSK Investigational Site, Westlake Village, California 91361, United States; Active, not recruiting

GSK Investigational Site, Sacramento, California 92585, United States; Recruiting

GSK Investigational Site, Garden Grove, California 92845, United States; Recruiting

GSK Investigational Site, Newport Beach, California 92660, United States; Recruiting

GSK Investigational Site, Fresno, California 93710, United States; Not yet recruiting

GSK Investigational Site, Northridge, California 91325, United States; Recruiting

GSK Investigational Site, Anaheim, California 92805, United States; Recruiting

GSK Investigational Site, San Francisco, California 94109, United States; Recruiting

GSK Investigational Site, East Hartford, Connecticut 06118-3239, United States; Recruiting

GSK Investigational Site, New Britain, Connecticut 06050, United States; Recruiting

GSK Investigational Site, Deland, Florida 32720, United States; Recruiting

GSK Investigational Site, Daytona Beach, Florida 32117, United States; Completed

GSK Investigational Site, Melbourne, Florida 32901, United States; Withdrawn

GSK Investigational Site, Fort Myers, Florida 33912, United States; Not yet recruiting

GSK Investigational Site, Atlanta, Georgia 30309, United States; Recruiting

GSK Investigational Site, Maywood, Illinois 60153, United States; Recruiting

GSK Investigational Site, Murray, Kentucky 42071, United States; Withdrawn

GSK Investigational Site, Shreveport, Louisiana 71103, United States; Not yet recruiting

GSK Investigational Site, Biddeford, Maine 04005, United States; Recruiting

GSK Investigational Site, Brockton, Massachusetts 02301, United States; Recruiting

GSK Investigational Site, Boston, Massachusetts 02115, United States; Withdrawn

GSK Investigational Site, Bingham Farms, Michigan 48025, United States; Withdrawn

GSK Investigational Site, Kalamazoo, Michigan 49009, United States; Recruiting

GSK Investigational Site, St. Louis Park, Minnesota 55426, United States; Withdrawn

GSK Investigational Site, Hattiesburg, Mississippi 39401, United States; Completed

GSK Investigational Site, Springfield, Missouri 65807, United States; Completed

GSK Investigational Site, St. Louis, Missouri 63141, United States; Recruiting

GSK Investigational Site, Las Vegas, Nevada 89146, United States; Withdrawn

GSK Investigational Site, Henderson, Nevada 89014, United States; Completed

GSK Investigational Site, Las Vegas, Nevada 89119, United States; Active, not recruiting

GSK Investigational Site, Cherry Hill, New Jersey 08034, United States; Withdrawn

GSK Investigational Site, Albuquerque, New Mexico 87108, United States; Completed

GSK Investigational Site, New York, New York 10022, United States; Completed

GSK Investigational Site, Schenectady, New York 12308, United States; Recruiting

GSK Investigational Site, Albany, New York 12206, United States; Recruiting

GSK Investigational Site, Hickory, North Carolina 28601, United States; Recruiting

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States; Recruiting

GSK Investigational Site, Minot, North Dakota 58704, United States; Completed

GSK Investigational Site, Fargo, North Dakota 58104, United States; Completed

GSK Investigational Site, Cleveland, Ohio 44122, United States; Recruiting

GSK Investigational Site, Columbus, Ohio 43210, United States; Completed

GSK Investigational Site, Dayton, Ohio 45406, United States; Recruiting

GSK Investigational Site, Cleveland, Ohio 44195, United States; Withdrawn

GSK Investigational Site, Greensburg, Pennsylvania 15601, United States; Recruiting

GSK Investigational Site, Philadelphia, Pennsylvania 19107-2568, United States; Recruiting

GSK Investigational Site, Warwick, Rhode Island 02886, United States; Completed

GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Withdrawn

GSK Investigational Site, Charleston, South Carolina 29412, United States; Completed

GSK Investigational Site, Beaufort, South Carolina 29902, United States; Not yet recruiting

GSK Investigational Site, Rapid City, South Dakota 57702, United States; Recruiting

GSK Investigational Site, Watertown, South Dakota 57201, United States; Withdrawn

GSK Investigational Site, Memphis, Tennessee 38018, United States; Withdrawn

GSK Investigational Site, Germantown, Tennessee 38139, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75214, United States; Withdrawn

GSK Investigational Site, San Antonio, Texas 78258, United States; Recruiting

GSK Investigational Site, Houston, Texas 77004, United States; Recruiting

GSK Investigational Site, Katy, Texas 77450, United States; Withdrawn

GSK Investigational Site, Austin, Texas 78745, United States; Recruiting

GSK Investigational Site, San Antonio, Texas 78229, United States; Recruiting

GSK Investigational Site, Alexandria, Virginia 22311, United States; Withdrawn

GSK Investigational Site, Alexandria, Virginia 22304, United States; Withdrawn

GSK Investigational Site, Virginia Beach, Virginia 23452, United States; Recruiting

GSK Investigational Site, Roanoke, Virginia 24013, United States; Withdrawn

GSK Investigational Site, Wenatchee, Washington 98801, United States; Withdrawn

GSK Investigational Site, Charleston, West Virginia 25301, United States; Withdrawn

Starting date: December 2007
Ending date: December 2008
Last updated: April 2, 2009