This study was designed to determine long-term safety of TREXIMA compared to placebo for the
treatment of acute migraine.
Inclusion Criteria:
- Subject is between 12 and 17 years old at the Screening visit.
- If subject is female, she must have a negative urine pregnancy test at screening, does
not plan to become pregnant during the course of the study and agrees to use an
acceptable method of birth control (i. e., a method with a failure rate <1% or
abstinence) if she is/becomes sexually active.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has history suggestive of typical migraine attacks with duration of about 2 or
more hours (untreated, or unsuccessfully treated).
- Subject has at least 2, but not more than 8, migraine attacks per month in each of the
2 months prior to the Screening visit.
- Subject has at least a 6-month history of moderate to severe migraine attacks,
sufficient to establish a definitive diagnosis of migraine.
- Subject is able to distinguish migraine from other headaches (e. g., tension-type
headaches).
- Subject and subject's parent or legal guardian are willing and able to provide
informed consent prior to entry into this treatment phase of the study.
- Subject and subject's parent or legal guardian are able to read and write English or
Spanish.
- Subject is able to understand and complete the electronic device to report treatment
information.
Exclusion Criteria:
- Subject is < 75 pounds (33. 3kg).
- Subject has ≥15 headache days per month in total, retinal (ICHD-II 1. 4), basilar
(ICHD-II 1. 26) or hemiplegic migraine (ICHD-II 1. 25), or secondary headaches.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular
or cerebrovascular disease (See Appendix 1, section 11. 1).
- Subject has uncontrolled hypertension (See Appendix 2, section 11. 2) or is taking any
angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
- Subject has a history of congenital heart disease, cardiac arrhythmias requiring
medication, or a history of a clinically significant electrocardiogram abnormality
that, in the investigator's opinion, contraindicates participation in this study.
- Subject has evidence or history of any ischemic vascular diseases including: ischemic
heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's
Syndrome, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of central nervous system pathology including stroke
and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which
lower the convulsive threshold; or has been treated with an antiepileptic drug for
seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function that, in the
investigator's opinion, contraindicates participation in this study.
- Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of
any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) 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
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 for treatment
of his/her 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 taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including
herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within
the 2 weeks prior to screening through 2 weeks post final study treatment.
- Subject history of any bleeding disorder or is currently taking any anti-coagulant or
any antiplatelet agent.
- Subject has evidence or history of any gastrointestinal surgery or GI ulceration or
perforation in the past six months, gastrointestinal bleeding in the past year; or
evidence or history of inflammatory bowel disease.
- Subject tests positive for illicit substances on toxicology screen, or has evidence of
alcohol or substance abuse within the last year, or any concurrent medical or
psychiatric condition which, in the investigator's judgment, will likely interfere
with the study conduct, subject cooperation, or evaluation and interpretation of the
study results, or which otherwise contraindicates participation in this clinical
trial.
- Subject has participated in an investigational drug trial within the previous 4 weeks
or plans to participate in another study at any time during this study.
Valley Neurological Headache and Research Center, Phoenix, Arizona 85014, United States; Recruiting
Carol Foster, MD, Phone: 602-331-3721
Carol Foster, MD, Principal Investigator
Neurological Physicians of Arizona, Inc., Gilbert, Arizona 85234, United States; Recruiting
William Grainger, MD, Phone: 480-610-0177
William Grainger, MD, Principal Investigator
Pediatric Neurology The Children's Clinic of Jonesboro, Jonesboro, Arkansas 72401, United States; Recruiting
Stephen Bates, MD, Phone: 870-935-6012
Stephen Bates, MD, Principal Investigator
Clinical Study Centers, Little Rock, Arkansas 72205, United States; Recruiting
Gordon Gibson, MD, Phone: 501-227-7499
Gordon Gibson, MD, Principal Investigator
Med Investigations, Fair Oaks, California 95628, United States; Recruiting
John Champlin, MD, Phone: 915-965-1111
John Champlin, MD, Principal Investigator
Fullerton Neurology and Headache, Fullerton, California 92835, United States; Recruiting
Jack Florin, MD, Phone: 714-738-0800
Jack Florin, MD, Principal Investigator
Stephen Forner, MD, Chico, California 95926, United States; Recruiting
Stephen Forner, MD, Phone: 530-894-3330
Stehpen Forner, MD, Principal Investigator
San Francisco Clinical Research Center and Headache Clinic, San Francisco, California 94109, United States; Recruiting
Jerome Goldstein, MD, Phone: 415-673-4600
Jerome Goldstein, MD, Principal Investigator
UCSDn Stroke Center, San Diego, California 92103, United States; Not yet recruiting
Christy Jackson, MD
Christy Jackson, MD, Principal Investigator
Kratzer-Graves Pediatrics, Fresno, California 93720, United States; Recruiting
James Kratzer, MD, Phone: 559-438-4100
James Kratzer, MD, Principal Investigator
California Medical Clinic for Headaches, Santa Monica, California 90404, United States; Recruiting
David Kudrow, MD, Phone: 310-315-1456
David Kudrow, MD, Principal Investigator
Irvine Center for Clinical Research Inc., Irvine, California 92618, United States; Recruiting
Elly Lee, MD, Phone: 949-753-1663
Elly Lee, MD, Principal Investigator
Philip O'Carroll MD Inc., Newport Beach, California 92660, United States; Recruiting
Philip O'Carroll, MD, Phone: 949-759-8001
Philip O'Carroll, MD, Principal Investigator
Pediatric Care, Huntington, California 92647, United States; Recruiting
Paul Qaqundah, MD, Phone: 714-842-1441
Paul Qaqundah, MD, Principal Investigator
South Bay Neurology Research Center, Redondo Beach, California 90277, United States; Recruiting
George Rederich, MD, Phone: 310-376-9492
George Rederich, MD, Principal Investigator
Socklov Medical Research, Sacramento, California 95825, United States; Recruiting
Ronald Sockolov, MD, Phone: 916-924-8707
Ronald Sockolov, MD, Principal Investigator
Neurological Research Institute of the East Bay, Walnut Creek, California 94596, United States; Recruiting
Michael Stein, MD, Phone: 925-938-5252
Michael Stein, MD, Principal Investigator
Adult and Child Neurology, Roseville, California 95678, United States; Recruiting
Nadine Yassa, MD, Phone: 916-789-8811
Nadine Yassa, MD, Principal Investigator
Northridge Neurological Center, Northridge, California 91325, United States; Recruiting
Ronald Ziman, MD, Phone: 818-349-2503
Ronald Ziman, MD, Principal Investigator
Mark S. Wallace, MD, La Jolla, California 92037, United States; Recruiting
Mark S Wallace, MD, Phone: 858-657-7030
Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States; Recruiting
Kurt Lesh, MD, Phone: 719-636-3784
Kurt Lesh, MD, Principal Investigator
The Children's Hospital - Denver Neurology, Denver, Colorado 80218, United States; Recruiting
Tonia Sabo, MD, Phone: 720-777-9249
Tonia Sabo, MD, Principal Investigator
Hartford Headache Center, Ridgfield, Connecticut 06877, United States; Recruiting
Tayna Bilchick, MD, Phone: 860-895-3133
Tayna Bilchick, MD, Principal Investigator
Associated Neurologist of Southern Connecticut, Fairfield, Connecticut 06824, United States; Recruiting
Anthony Hong, MD, Phone: 203-333-1151
Anthony Hong, MD, Principal Investigator
Anchor Reserach A Division of Anchor Health Centers, Naples, Florida 72401, United States; Not yet recruiting
Cynthia Bell, MD, Phone: 239-262-4556
Cynthia Bell, MD, Principal Investigator
Suncoast Medical Group, St. Petersburg, Florida 33701, United States; Recruiting
Steven Cohen, MD, Phone: 727-824-7135
Steven Cohen, MD, Principal Investigator
Suncoast Medical, St. Petersberg, Florida 33701, United States; Recruiting
Steven Cohen, MD, Phone: 727-824-7132
Steven Cohen, MD, Principal Investigator
Pediatric Neurology and Epilepsy Center, Loxahatchee, Florida 33470, United States; Recruiting
Edwin Liu, MD, Phone: 561-753-8888
Edwin Liu, MD, Principal Investigator
Child Neurology Clinic, Pensacola, Florida 32504, United States; Recruiting
James Ben Renfroe, MD, Phone: 850-484-6060
James Renfroe, MD, Principal Investigator
Premiere Research Institute, West Palm Beach, Florida 33407, United States; Recruiting
Paul K Winner, MD, Phone: 561-845-0500
K Winner, MD, Principal Investigator
Savannah Neurology, PC, Savannah, Georgia 31405, United States; Recruiting
Eric Pearlman, MD, Phone: 912-353-3333
Eric Pearlman, MD, Principal Investigator
Child Neurology Associates, P.C., Atlanta, Georgia 30342, United States; Recruiting
Frank Berenson, MD, Phone: 404-256-3535
Frank Berenson, MD, Principal Investigator
Pediatric Neurology of Idaho, Boise, Idaho 83712, United States; Not yet recruiting
David Bettis, MD
David Bettis, MD, Principal Investigator
Community Clinical Research Center, Anderson, Indiana 46011, United States; Recruiting
Larry Blankenship, Jr., MD, Phone: 765-648-2420
Larry Blankenship, Jr., MD, Principal Investigator
Vince & Associates, Overland Park, Kansas 66212, United States; Not yet recruiting
Brad Vince, MD
Brad Vince, MD, Principal Investigator
CNS Associates, Inc., Murray, Kentucky 42071, United States; Recruiting
Jon Gustafson, MD, Phone: 270-753-8656
Jon Gustafson, MD, Principal Investigator
Kentucky Pediatric/Adult Relationship, Bardstown, Kentucky 40004, United States; Recruiting
James Hedrick, MD, Phone: 502-348-6309
James Hedrick, MD, Principal Investigator
Child and Adolescent Neurology, Bethesda, Maryland 20817, United States; Not yet recruiting
Jody Green, MD
Jody Green, MD, Principal Investigator
ProMed Pediatrics, Protage, Michigan 49024, United States; Recruiting
Thomas Akland, MD, Phone: 269-329-0944
Thomas Akland, MD, Principal Investigator
Women's Health Care Specialists, P.C., Paw Paw, Michigan 49079, United States; Recruiting
Roger Beyer, MD, Phone: 269-657-6058
Roger Beyer, MD, Principal Investigator
ProMed Pediatrics, Kalamazoo, Michigan 97210, United States; Not yet recruiting
Jerald Finnegan, MD, Phone: 269-381-3500
Jerald Finnegan, MD, Principal Investigator
Michigan Head Pain & Neurological Institute, Ann Arbor, Michigan 48104, United States; Recruiting
Charles Gordon, MD, Phone: 734-677-6000
Charles Gordon, MD, Principal Investigator
Borgess Research Institute, Kalamazoo, Michigan 49043, United States; Recruiting
Sandra Wiederhold, MD, Phone: 269-552-2500
Sandra Wiederhold, MD, Principal Investigator
Clinical Research Institute, Minneapolis, Minnesota 55402, United States; Recruiting
Gary Berman, MD, Phone: 612-333-2200
Gary Berman, MD, Principal Investigator
Mercy Health Research Ryan Headache Center, St. Louis, Missouri 63141, United States; Recruiting
Jim Banks III, MD, Phone: 314-251-8890
Jim Banks, MD, Principal Investigator
Midwest Allergy and Asthma Clinic, Omaha, Nebraska 68130, United States; Not yet recruiting
Tom Nilsson, MD
Tom Nilsson, MD, Principal Investigator
Lovelace Scientific Resources, Inc., Las Vegas, Nevada 89148, United States; Recruiting
Shanker Dixit, MD, Phone: 702-796-5505
Shanker Dixit, MD, Principal Investigator
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Not yet recruiting
Levin Morris, MD
Levin Morris, MD, Principal Investigator
Childrens Neurology, Morristown, New Jersey 07960, United States; Not yet recruiting
Trevor De Souza, MD
Trevor De Souza, MD, Principal Investigator
Pediatric Clinical Research Center, New Brunswick, New Jersey 08901, United States; Recruiting
Rajeshwari Mahalingam, MD, Phone: 732-235-7875
Rajeshwari Mahalingam, MD, Principal Investigator
The Center for Neurological & Neurodevelopmental Health Clinical Research Center of New Jersey, Voorhees, New Jersey 08043, United States; Recruiting
Mark Mintz, MD, Phone: 856-616-6439
Mark Mintz, MD, Principal Investigator
Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States; Recruiting
Eileen Brady, MD, Phone: 505-348-9500
Eileen Brady, MD, Principal Investigator
Braverman-Panza Medical Group, Albany, New York 12206, United States; Recruiting
Jill Braverman-Panza, MD, Phone: 518-482-0007
Jill Braverman-Panza, MD, Principal Investigator
Rochester Clinical Research, Rochester, New York 14609, United States; Recruiting
Matthew Davis, MD, Phone: 585-288-0890
Matthew Davis, MD, Principal Investigator
University of Rochester, Rochester, New York 14642, United States; Recruiting
Deborah Friedman, MD, Phone: 585-273-3937
Deborah Friedman, MD, Principal Investigator
Gosy & Associates Pain Treatment and Neurology, LLP, Williamsville, New York 14221, United States; Recruiting
Eugene Gosy, MD, Phone: 716-626-9900
Eugene Gosy, MD, Principal Investigator
The Elkind Headache Clinic, Mt Vernon, New York 10550, United States; Recruiting
Arthur H Elkind, MD, Phone: 914-668-6195
Arthur H Elkind, MD, Principal Investigator
Neurology Group of Bergen County, P. A., Ridgewood, New York 07450, United States; Not yet recruiting
Kenneth Levin, MD, Phone: 201-444-0868
Kenneth Levin, MD, Principal Investigator
Dent Neurologic Institute, Amherst, New York 14226, United States; Recruiting
Laszlo Mechtler, MD, Phone: 716-961-9900
Laszlo Machtler, MD, Principal Investigator
Analgesic Development Ltd., New York, New York 10022, United States; Not yet recruiting
Serena Mulhern, MD, Phone: 212-249-2550
Serena Mulhern, MD, Principal Investigator
Regional Clinical Research, Endwell, New York 13760, United States; Recruiting
Duncan Sze-Tu, MD, Phone: 607-754-3863
Duncan Sze-Tu, MD, Principal Investigator
Island Neurological Associates, Plainview, New York 11803, United States; Recruiting
Ira Turner, MD, Phone: 516-822-2230
Ira Turner, MD, Principal Investigator
Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States; Recruiting
Kevin Rathke, MD, Phone: 919-782-3456
Kevin Rathke, MD, Principal Investigator
Cincinnati Children's Hospital, Cincinnati, Ohio 45229, United States; Recruiting
Andrew Hershey, MD, Phone: 513-636-4222
Andrew Hershey, MD, Principal Investigator
OrthoNeuro, Westerville, Ohio 43018, United States; Recruiting
Francis O'Donnell, MD, Phone: 614-890-6555
Francis O'Donnell, MD, Principal Investigator
Childrens Hospital, Columbus, Ohio 43018, United States; Recruiting
Ann Pakalnis, MD, Phone: 614-722-2000
Ann Pakalnis, MD, Principal Investigator
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
David Rothner, MD, Phone: 216-444-5514
David Rothner, MD, Principal Investigator
Lynn Health Science Institute, Oklahama City, Oklahoma 73112, United States; Recruiting
Mark Fisher, MD, Phone: 405-602-3939
Mark Fisher, MD, Principal Investigator
Pacific Women's Center, Eugene, Oregon 97401, United States; Recruiting
Richard Beyerlein, MD, Phone: 541-342-8616
Richard Beyerlein, MD, Principal Investigator
Medford Neurologic Spine Center, Medford, Oregon 97504, United States; Recruiting
Walter Carlini, MD, Phone: 541-779-1672
Carlini Walter, MD, Principal Investigator
Oregon Center for Clinical Investigations, Inc., Portland, Oregon 97210, United States; Recruiting
Beal Essink, MD, Phone: 503-276-6224
Beal Essink, MD, Principal Investigator
Mountain View Clinical Research, Greer, South Carolina 29349, United States; Recruiting
Phillip Snell, MD, Phone: 864-334-0141
Phillip Snell, MD, Principal Investigator
Nashville Neurosciences Group, Nashville, Tennessee 37203, United States; Recruiting
Jan Brandes, MD, Phone: 615-284-4680
Jan Brandes, MD, Principal Investigator
Neurology, Headache & Pain Control Center, Nassau Bay, Texas 77058, United States; Recruiting
Moshe Allon, MD, Phone: 281-338-7246
Allon Moshe, MD, Principal Investigator
Texas Child Neurology, Plano, Texas 75075, United States; Recruiting
Robert Chudnow, MD, Phone: 972-769-9000
Robert Chudnow, MD, Principal Investigator
Radiant Research, San Antonio, Texas 78229, United States; Recruiting
William Jennings, MD, Phone: 210-614-7483
William Jennings, MD, Principal Investigator
Dallas Pediatric Neurology Associates, Dallas, Texas 75230-2507, United States; Recruiting
Steven Linder, MD, Phone: 972-566-8600
Steven Linder, MD, Principal Investigator
Georgetown Medical Center Clinic, Georgetown, Texas 78628, United States; Recruiting
John Willis, MD, Phone: 512-930-4593
John Willis, MD, Principal Investigator
Foothill Family Clinic South, Salt Lake City, Utah 84121, United States; Recruiting
Shane Christensen, MD, Phone: 801-365-1032
Shane Christensen, MD, Principal Investigator
J. Lewis Research, Inc., Salt Lake City, Utah 84109, United States; Recruiting
Dan Henry, MD, Phone: 801-487-2072
Dan Henry, MD, Principal Investigator
Monarch Medical Research, Norfolk, Virginia 23510, United States; Recruiting
Donald Lewis, MD, Phone: 757-668-9920
Donald Lewis, MD, Principal Investigator
Pedeatric Research of Charlottesville, LLC, Charolottesville, Virginia 22902, United States; Recruiting
Paul Wisman, MD, Phone: 434-326-0411
Paul Wisman, MD, Principal Investigator
Kitsap Center for Clinical Studies, Bremerton, Washington 98310, United States; Recruiting
Donald Bright, MD, Phone: 360-377-9079
Donald Bright, MD, Principal Investigator
Wenatchee Valley Medical Center, Wenatchee, Washington 98801, United States; Recruiting
Steven Kaster, MD, Phone: 509-665-5800
Steven Kaster, MD, Principal Investigator
