TREXIMA Versus Butalbital-Containing Combination Medications for the Acute Treatment of Migraine in Adults

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, 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 TRX109011, 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 00926, Puerto Rico; Withdrawn

GSK Investigational Site, Carolina 00983, Puerto Rico; Withdrawn

GSK Investigational Site, Tempe, Arizona 85283, United States; Completed

GSK Investigational Site, Litchfield Park, Arizona 85340, United States; Completed

GSK Investigational Site, Sun City, Arizona 85351, United States; Withdrawn

GSK Investigational Site, Chandler, Arizona 85224, United States; Completed

GSK Investigational Site, Phoenix, Arizona 85015, United States; Withdrawn

GSK Investigational Site, Little Rock, Arkansas 72201, United States; Recruiting

GSK Investigational Site, Irvine, California 92618, United States; Recruiting

GSK Investigational Site, San Diego, California 92108, United States; Recruiting

GSK Investigational Site, Sherman Oaks, California 91403, United States; Recruiting

GSK Investigational Site, Encinitas, California 92024, United States; Withdrawn

GSK Investigational Site, Santa Monica, California 90404, United States; Recruiting

GSK Investigational Site, Los Angeles, California 90033, United States; Withdrawn

GSK Investigational Site, Aliso Viejo, California 92656, United States; Withdrawn

GSK Investigational Site, Fresno, California 93720, United States; Withdrawn

GSK Investigational Site, Walnut Creek, California 94596, United States; Recruiting

GSK Investigational Site, Pasadena, California 91106, United States; Withdrawn

GSK Investigational Site, Chino, California 91710, United States; Withdrawn

GSK Investigational Site, Garden Grove, California 92845, United States; Withdrawn

GSK Investigational Site, San Diego, California 92103-8411, United States; Withdrawn

GSK Investigational Site, Orange, California 92868, United States; Withdrawn

GSK Investigational Site, Anaheim, California 92801, United States; Not yet recruiting

GSK Investigational Site, Colorado Springs, Colorado 80909, United States; Recruiting

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States; Withdrawn

GSK Investigational Site, Aurora, Colorado 80012, United States; Withdrawn

GSK Investigational Site, Boulder, Colorado 80304, United States; Withdrawn

GSK Investigational Site, Stamford, Connecticut 06902, United States; Withdrawn

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

GSK Investigational Site, Waterbury, Connecticut 06708, United States; Withdrawn

GSK Investigational Site, Wilmington, Delaware 19806, United States; Withdrawn

GSK Investigational Site, Washington, District of Columbia 20037, United States; Withdrawn

GSK Investigational Site, Washington, District of Columbia 20060, United States; Withdrawn

GSK Investigational Site, Miami, Florida 33143, United States; Withdrawn

GSK Investigational Site, Naples, Florida 34102, United States; Recruiting

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

GSK Investigational Site, West Palm Beach, Florida 33407-2450, United States; Recruiting

GSK Investigational Site, Jacksonville, Florida 32266, United States; Withdrawn

GSK Investigational Site, Fort Myers, Florida 33912, United States; Withdrawn

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

GSK Investigational Site, Plantation, Florida 33324, United States; Recruiting

GSK Investigational Site, Jacksonville, Florida 32216, United States; Withdrawn

GSK Investigational Site, Pembroke Pines, Florida 33024, United States; Recruiting

GSK Investigational Site, Maitland, Florida 32751, United States; Withdrawn

GSK Investigational Site, Clearwater, Florida 33755, United States; Recruiting

GSK Investigational Site, Stockbridge, Georgia 30281, United States; Withdrawn

GSK Investigational Site, Royston, Georgia 30662, United States; Withdrawn

GSK Investigational Site, Marietta, Georgia 30060, United States; Withdrawn

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

GSK Investigational Site, Atlanta, Georgia 30342, United States; Withdrawn

GSK Investigational Site, Savannah, Georgia 31405, United States; Withdrawn

GSK Investigational Site, Smyrna, Georgia 30080, United States; Withdrawn

GSK Investigational Site, Jesup, Georgia 31545, United States; Withdrawn

GSK Investigational Site, Suwanee, Georgia 30024, United States; Recruiting

GSK Investigational Site, Rome, Georgia 30165, United States; Completed

GSK Investigational Site, Atlanta, Georgia 30308, United States; Withdrawn

GSK Investigational Site, Roswell, Georgia 30076, United States; Withdrawn

GSK Investigational Site, Savannah, Georgia 31406, United States; Active, not recruiting

GSK Investigational Site, Atlanta, Georgia 30342, United States; Active, not recruiting

GSK Investigational Site, Atlanta, Georgia 30308, United States; Completed

GSK Investigational Site, Chicago, Illinois 60614, United States; Active, not recruiting

GSK Investigational Site, Gurnee, Illinois 60031, United States; Recruiting

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

GSK Investigational Site, Chicago, Illinois 60637, United States; Withdrawn

GSK Investigational Site, Urbana, Illinois 61801, United States; Withdrawn

GSK Investigational Site, Evansville, Indiana 47714, United States; Withdrawn

GSK Investigational Site, Evansville, Indiana 47712, United States; Withdrawn

GSK Investigational Site, Indianapolis, Indiana 46256, United States; Completed

GSK Investigational Site, Lenexa, Kansas 66214, United States; Withdrawn

GSK Investigational Site, Lexington, Kentucky 40503, United States; Withdrawn

GSK Investigational Site, Paducah, Kentucky 42003, United States; Recruiting

GSK Investigational Site, Shreveport, Louisiana 71101, United States; Recruiting

GSK Investigational Site, Shreveport, Louisiana 71103, United States; Withdrawn

GSK Investigational Site, New Orleans, Louisiana 70121, United States; Not yet recruiting

GSK Investigational Site, Rockville, Maryland 20852, United States; Withdrawn

GSK Investigational Site, Westfield, Massachusetts 01085, United States; Withdrawn

GSK Investigational Site, Springfield, Massachusetts 01104, United States; Recruiting

GSK Investigational Site, Worcester, Massachusetts 1605, United States; Withdrawn

GSK Investigational Site, Lenox, Massachusetts 01240, United States; Withdrawn

GSK Investigational Site, Plymouth, Massachusetts 02360, United States; Withdrawn

GSK Investigational Site, Flint, Michigan 48506, United States; Withdrawn

GSK Investigational Site, Troy, Michigan 48098, United States; Withdrawn

GSK Investigational Site, Okemos, Michigan 48864, United States; Withdrawn

GSK Investigational Site, Farmington Hills, Michigan 48334, United States; Withdrawn

GSK Investigational Site, Ann Arbor, Michigan 48104, United States; Withdrawn

GSK Investigational Site, Ann Arbor, Michigan 48104, United States; Recruiting

GSK Investigational Site, Kalamazoo, Michigan 49008, United States; Withdrawn

GSK Investigational Site, Rochester, Minnesota 55905, United States; Withdrawn

GSK Investigational Site, Las Vegas, Nevada 89104, United States; Withdrawn

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

GSK Investigational Site, Derry, New Hampshire 03038, United States; Withdrawn

GSK Investigational Site, Lebanon, New Hampshire 03756, United States; Withdrawn

GSK Investigational Site, Ridgewood, New Jersey 7450, United States; Withdrawn

GSK Investigational Site, Toms River, New Jersey 08753, United States; Withdrawn

GSK Investigational Site, Berlin, New Jersey 08009, United States; Withdrawn

GSK Investigational Site, Ridgewood, New Jersey 07550, United States; Withdrawn

GSK Investigational Site, Cherry Hill, New Jersey 08002, United States; Recruiting

GSK Investigational Site, Ridgewood, New Jersey 7450, United States; Completed

GSK Investigational Site, Stratford, New Jersey 08084, United States; Recruiting

GSK Investigational Site, Haddon Heights, New Jersey 08035, United States; Withdrawn

GSK Investigational Site, Brooklyn, New York 11235, United States; Withdrawn

GSK Investigational Site, Rochester, New York 14642, United States; Withdrawn

GSK Investigational Site, Syracuse, New York 13210, United States; Withdrawn

GSK Investigational Site, Brooklyn, New York 11235, United States; Recruiting

GSK Investigational Site, Syracuse, New York 13210, United States; Recruiting

GSK Investigational Site, Mount Vernon, New York 10550, United States; Recruiting

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

GSK Investigational Site, Endwell, New York 13760, United States; Withdrawn

GSK Investigational Site, Valley Stream, New York 11580, United States; Completed

GSK Investigational Site, Bronx, New York 10461, United States; Completed

GSK Investigational Site, New York, New York 10021, United States; Completed

GSK Investigational Site, Camillus, New York 13031, United States; Withdrawn

GSK Investigational Site, Lawrence, New York 11559, United States; Withdrawn

GSK Investigational Site, Albany, New York 12208, United States; Withdrawn

GSK Investigational Site, Orchard Park, New York 14127, United States; Recruiting

GSK Investigational Site, Albany, New York 12205, United States; Recruiting

GSK Investigational Site, Raleigh, North Carolina 27612, United States; Withdrawn

GSK Investigational Site, Charlotte, North Carolina 28204, United States; Completed

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

GSK Investigational Site, Charlotte, North Carolina 28204, United States; Withdrawn

GSK Investigational Site, Greenville, North Carolina 27834, United States; Not yet recruiting

GSK Investigational Site, Gastonia, North Carolina 28054, United States; Withdrawn

GSK Investigational Site, Wilmington, North Carolina 28401, United States; Recruiting

GSK Investigational Site, Cary, North Carolina 27518, United States; Recruiting

GSK Investigational Site, Bismarck, North Dakota 58501, United States; Completed

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

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

GSK Investigational Site, Columbus, Ohio 43213, United States; Withdrawn

GSK Investigational Site, Akron, Ohio 44302, United States; Withdrawn

GSK Investigational Site, Tiffin, Ohio 44883, United States; Withdrawn

GSK Investigational Site, Cincinnati, Ohio 45227, United States; Recruiting

GSK Investigational Site, Toledo, Ohio 43614-5809, United States; Recruiting

GSK Investigational Site, Cincinnati, Ohio 45245, United States; Recruiting

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States; Recruiting

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States; Withdrawn

GSK Investigational Site, Norman, Oklahoma 73071, United States; Withdrawn

GSK Investigational Site, Yukon, Oklahoma 73099, United States; Withdrawn

GSK Investigational Site, Tulsa, Oklahoma 74137, United States; Withdrawn

GSK Investigational Site, Tulsa, Oklahoma 74136, United States; Withdrawn

GSK Investigational Site, Portland, Oregon 97213, United States; Withdrawn

GSK Investigational Site, Eugene, Oregon 97401, United States; Withdrawn

GSK Investigational Site, Portland, Oregon 97239, United States; Withdrawn

GSK Investigational Site, Ashland, Oregon 97520, United States; Withdrawn

GSK Investigational Site, Natrona Heights, Pennsylvania 15065, United States; Withdrawn

GSK Investigational Site, Philadelphia, Pennsylvania 19114, United States; Recruiting

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States; Completed

GSK Investigational Site, Pittsburgh, Pennsylvania 15236, United States; Recruiting

GSK Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Withdrawn

GSK Investigational Site, Media, Pennsylvania 19063, United States; Withdrawn

GSK Investigational Site, Mount Pleasant, South Carolina 29464, United States; Withdrawn

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

GSK Investigational Site, Greenville, South Carolina 29605, United States; Withdrawn

GSK Investigational Site, Simpsonville, South Carolina 29681, United States; Completed

GSK Investigational Site, Beaufort, South Carolina 29902, United States; Withdrawn

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

GSK Investigational Site, Columbia, Tennessee 38401, United States; Completed

GSK Investigational Site, Cordova, Tennessee 38018, United States; Completed

GSK Investigational Site, Knoxville, Tennessee 37923, United States; Withdrawn

GSK Investigational Site, Johnson City, Tennessee 37604, United States; Withdrawn

GSK Investigational Site, Nashville, Tennessee 37203, United States; Completed

GSK Investigational Site, Austin, Texas 78756, United States; Withdrawn

GSK Investigational Site, El Paso, Texas 79902, United States; Withdrawn

GSK Investigational Site, Dallas, Texas 75203, United States; Withdrawn

GSK Investigational Site, Round Rock, Texas 78681, United States; Withdrawn

GSK Investigational Site, Dallas, Texas 75231, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75231, United States; Withdrawn

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

GSK Investigational Site, Houston, Texas 77074, United States; Withdrawn

GSK Investigational Site, Dallas, Texas 75234, United States; Recruiting

GSK Investigational Site, Salt Lake City, Utah 84121, United States; Withdrawn

GSK Investigational Site, Salt Lake City, Utah 84107, United States; Recruiting

GSK Investigational Site, Midlothian, Virginia 23112, United States; Withdrawn

GSK Investigational Site, Richmond, Virginia 23298, United States; Withdrawn

GSK Investigational Site, Herndon, Virginia 20170, United States; Withdrawn

GSK Investigational Site, Tacoma, Washington 98401, United States; Withdrawn

GSK Investigational Site, Seattle, Washington 98104, United States; Withdrawn

GSK Investigational Site, Racine, Wisconsin 53404, United States; Withdrawn

Starting date: February 2008
Ending date: August 2009
Last updated: April 2, 2009