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: Pozen

Official(s) and/or principal investigator(s):
Deo S Bukeyna, Pharm D, Study Chair, Affiliation: GlaxoSmithKline

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: 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)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, 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: 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.

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.

Clinical Research Advantage, Inc., Chandler, Arizona 85224, United States; Not yet recruiting
Donna DeSantis, MD

Arizona Neurological Institute, Sun City, Arizona 85351, United States; Not yet recruiting
Eric Eross, MD

Fiel Family and Sports Medicine, Tempe, Arizona 85283, United States; Not yet recruiting
Thomas Fiel, MD

Valley Neurological Headache and Research, Phoenix, Arizona 85014, United States; Not yet recruiting
Carol Foster, MD

Clinical Reserach Advantage, Inc., Gilbert, Arizona 85234, United States; Not yet recruiting
William Grainger, MD

Brown Road Family Medicine, Mesa, Arizona 85213, United States; Not yet recruiting
Gerald Shockey, MD

K and S Professional Services, Little Rock, Arkansas 72204, United States; Not yet recruiting
Gregory Kaczenski, MD

Clinical Study Centers, LLC, Little Rock, Arkansas 72205, United States; Not yet recruiting
Gordon Gibson, MD

Little Rock Family Practice Clinic, Little Rock, Arkansas 72205, United States; Not yet recruiting
Kevin Roberts, MD

Clarence E. Ballard, MD, Little Rock, Arkansas 72201, United States; Recruiting
Clarence E Ballard, MD, Phone: 501-378-0400

Medical Center for Clinical Research, San Diego, California 92108, United States; Not yet recruiting
William Koltun, MD

California Medical Clinic for Headaches, Santa Monica, California 90404, United States; Not yet recruiting
David Kudrow, MD

Advanced Clinical Reserach Institute, Anaheim, California 92801, United States; Not yet recruiting
Dennis Riff, MD

Neurological Research Institute of the East Bay, Walnut Creek, California 94596, United States; Not yet recruiting
Michael Stein, MD

San Francisco Clinical Research Center & Headache Clinic, San Francisco, California 94109, United States; Not yet recruiting
Jerome Goldstein, MD

Saad Hijazi, M.D., Inc., Fresno, California 93710, United States; Not yet recruiting
Saad Hijazi, MD

Waseem N. Ibrahim, MD, Inc., Riverside, California 92501, United States; Not yet recruiting
Waseem Ibrahim, MD

Clinical Neurology and Electromyography, Newport Beach, California 92660, United States; Not yet recruiting
C. Phillip O'Carroll, MD

Westlake Medical Research, Westlake Village, California 91361, United States; Not yet recruiting
Edward Portnoy

Thomas Jefferson University, Jefferson Headache Center, Dept. of Neurology, Sacramento, California 95825, United States; Not yet recruiting
Stephen Silberstein, MD

Ronald Socklov, MD, Sacramento, California 95825, United States; Not yet recruiting
Ronald Sockolov, MD

Northridge Neurological Center, Northridge, California 91325, United States; Not yet recruiting
Ronald Ziman, MD

The Hartford Headache Center, Ridgefield, Connecticut 06877, United States; Not yet recruiting
Tayna Bilchik, MD

Neurology Clinical Research, Inc., Sunrise, Florida 33351, United States; Not yet recruiting
Barry Cutler, MD

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States; Not yet recruiting
Larry Gilderman, MD

Covance CRU, Inc., Daytona Beach, Florida 32117, United States; Not yet recruiting
H. Farmer, MD

Mima Century Research Associates, Melbourne, Florida 32901, United States; Not yet recruiting
William Sunter, MD

Laszlo J. Mate, MD, West Palm Beach, Florida 33407, United States; Not yet recruiting
Laszlo J Mate, MD

Child Neurology Associates, Atlanta, Georgia 30342, United States; Not yet recruiting
Frank Berenson, MD

Comprehensive Neurology Specialists, PC, Suwanee, Georgia 30024, United States; Not yet recruiting
Mark Harris, MD

Radiant Research Altanta West, Atlanta, Georgia 30308, United States; Not yet recruiting
Robert Kaufmann, MD

Harbin Clinic, Rome, Georgia 30165, United States; Not yet recruiting
Jay Schecter, MD

South Coast Medical Group, Savannah, Georgia 31406, United States; Not yet recruiting
Robert Weeks, MD

Neuro Care Center of Atlanta, Atlanta, Georgia 30309, United States; Not yet recruiting
Eric Awad, MD

Diamond Headache Clinic, Chicago, Illinois 60614, United States; Not yet recruiting
Fred Freitag, MD

Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana 46256, United States; Not yet recruiting
Craig Herrman, MD

Clinical Trials of America, Shrefeport, Louisiana 71101, United States; Not yet recruiting
Susan Kemp, MD

LSU Health Sciences Center, Shreveport, Louisiana 71103, United States; Not yet recruiting
Debra Elliott, MD

PrimeCare Physicians, Biddeford, Maine 04005, United States; Not yet recruiting
Richard Kahn, MD

Mid-Atlantic Headache Ctr., Baltimore, Maryland 21208, United States; Not yet recruiting
Marcia Ribeiro, MD

Beacon Clinical Research, Brockton, Massachusetts 02301, United States; Not yet recruiting
David Chen, MD

BMC/BUSM, Boston, Massachusetts, United States; Not yet recruiting
Brian McGeeney, MD

Michigan Head Pain & Neuro Institute, Ann Arbor, Michigan 48104, United States; Not yet recruiting
Charles Gordon, MD

United Physicians, Bingham Farms, Michigan 48025, United States; Not yet recruiting
Steve Schechter, MD

Neurological Research Center at Hattiesburg Clinic, Hattiesburg, Mississippi 39401, United States; Not yet recruiting
Ronald Schwartz, MD

Mercy Health Research, St. Louis, Missouri 63141, United States; Not yet recruiting
James Banks, MD

Clinvest, Springfield, Missouri 65807, United States; Not yet recruiting
Chris Schreiber, MD

Clinical Research Consortium, Las Vegas, Nevada 89119, United States; Not yet recruiting
V. Jerome Mirkil, MD

Lovelace Scientific, Henderson, Nevada 89104, United States; Not yet recruiting
Frederick Tanenggee, MD

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03788, United States; Not yet recruiting
Morris Levin, MD

Neurology Group of Bergen County, Ridgewood, New Jersey 07450, United States; Not yet recruiting
Kenneth Levin, MD

UMDNJ-SOM-Cherry Hill, University Doctor's Family Medicine, Cherry Hill, New Jersey 08002, United States; Not yet recruiting
Robert Hudrick, MD

Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States; Not yet recruiting
Eileen Brady, MD

Upstate Clinical Research, Albany, New York 12205, United States; Not yet recruiting
Christopher Calder, MD

North Shore Pain Serices, Valley Stream, New York 11580, United States; Not yet recruiting
Grace Forde, MD

Montefiore Headache Center, Bronx, New York 10461, United States; Not yet recruiting
Brian Grosberg, MD

The Elkind Headache Clinic, Mt. Vernon, New York 10550, United States; Not yet recruiting
Gary Ishkanian

New York Headache Center, New York, New York 10021, United States; Not yet recruiting
Alexander Mauskop, MD

Dent Neurologic Institute, Amherst, New York 14226, United States; Not yet recruiting
Laszlo Mechtler, MD

SUNY Upstate Medical University, Syracuse, New York 13202, United States; Not yet recruiting
Luis Mejico, MD

Breverman-Panza Medical Group, Albany, New York 12206, United States; Not yet recruiting
Jill Braverman-Panza, MD

Analgesic Development Ltd., New York, New York 10022, United States; Not yet recruiting
Serena Mulhern, MD

Neurology Associates of Northeastern NY, PC, Schenectady, New York 12308, United States; Not yet recruiting
Bruno Tolge, MD

East Carolina Neurology, Greenville, North Carolina 27834, United States; Not yet recruiting
James B Cooper, MD

The Neurological Institute, PA, Charlotte, North Carolina 28204, United States; Not yet recruiting
T. Nemanth Rao

Hickory Family Practice MedTrials, Inc., Hickory, North Carolina 29601, United States; Not yet recruiting
Michael DeSantis, MD

Clinical Research of Winston-Salem, Inc., Winston Salem, North Carolina 27103, United States; Not yet recruiting
Andreas Runheim, MD

Kirkwood/Mid Dakota Clinic, Bismarck, North Dakota 58501, United States; Not yet recruiting
Shelly Seifert, MD

Trinity Hospitals, Minot, North Dakota 58704, United States; Not yet recruiting
Kurt Datz, MD

Dakota Clinic/Innovis Health, Fargo, North Dakota 58104, United States; Not yet recruiting
Thomas Kempf, MD

Community Research, Cincinnati, Ohio 45227, United States; Not yet recruiting
Antoinette Pragalos, MD

Univ of Toledo, Toledo, Ohio 43614, United States; Not yet recruiting
Gretchen Tietjen, MD

Coummunity Research, Cincinnati, Ohio 45245, United States; Not yet recruiting
Tamela Zimmerman, MD

The Ohio State University Medical Center, Columbus, Ohio 43210, United States; Not yet recruiting
Yousef Mohammad, MD

Dayton Clinical Research, Dayton, Ohio 45406, United States; Not yet recruiting
Martin Schear, MD

Clevland Clinic, Cleveland, Ohio 44195, United States; Not yet recruiting
Mark Stillman, MD

Neurological Center-OK, Inc., Tulsa, Oklahoma 74136, United States; Not yet recruiting
Gregory Connor, MD

Preferred Primary Care, Pittsburgh, Pennsylvania 15235, United States; Not yet recruiting
Nathan Bennett, MD

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19114, United States; Not yet recruiting
Larry Seidman, MD

Drexel University, Philadelphia, Pennsylvania 19102, United States; Not yet recruiting
David Tabby, MD

Westmorland Neurology, Greensburg, Pennsylvania 15601, United States; Not yet recruiting
Michael Sauter, MD

NeuroHealth Inc., Warwick, Rhode Island, United States; Not yet recruiting
Gary L'Europa, MD

Hillcrest Clinical Research, LLC, Simpsonville, South Carolina 29681, United States; Not yet recruiting
Robert Broker, MD

Velocity Clinical Research, Charleston, South Carolina 29412, United States; Not yet recruiting
Hugh Durrence

Coastal Neurology, Beaufort, South Carolina 29902, United States; Not yet recruiting
Paul Mazzeo, MD

Odyssey Research Brown Clinic, P.L.L.P, Watertown, South Dakota 57201, United States; Not yet recruiting
Jonathan McAreavey, MD

Nashville Neuroscience Group, PC, Nashville, Tennessee 37203, United States; Not yet recruiting
Jan Brandes, MD

Neurology Clinical PC, Cordova, Tennessee 38108, United States; Not yet recruiting
Raja Khan, MD

Neurology Center of Middle TN, Columbia, Tennessee 38401, United States; Not yet recruiting
Lucy Ledbetter, MD

MidSouth Neurology, Germantown, Tennessee 38139, United States; Not yet recruiting
Maroun Dick, MD

Integra Clinical, San Antonio, Texas 78229, United States; Not yet recruiting
Ales Gregory, MD

Innovative Clinical Trials, San Antonio, Texas 78229, United States; Not yet recruiting
James Garrison, MD

Clinical Researches of South Texas, Katy, Texas 77450, United States; Not yet recruiting
Isabel Martinez, MD

Houston Headache Clinic, Houston, Texas 77004, United States; Not yet recruiting
Ninan Mathew, MD

Texas Headaches Associates, San Antonio, Texas 78258, United States; Not yet recruiting
Robert Nett, MD

Eric Weidmann MD Primary Care-Austin, Austin, Texas 78745, United States; Not yet recruiting
Eric Weidmann, MD

Wasatch Clinical Research, Salt Lake City, Utah 84107, United States; Not yet recruiting
David Smith, MD

Brighton Research Group, LLC, Virginia Beach, Virginia 23452, United States; Not yet recruiting
Neil Pugach, MD

Starting date: December 2007
Ending date: December 2008
Last updated: May 6, 2008