TREXIMA for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

Condition(s) targeted: Migraine Disorders

Intervention: sumatriptan succinate / naproxen sodium (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Pozen

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

This study was designed to determine the efficacy and tolerability of TREXIMA compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Tolerability of TREXIMA(tm) (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Score on a migraine pain scale at 2 hours through 24 hours for a single probable migraine attack.

Secondary outcome: Freedom from all migraine pain and symptoms, satisfaction, recurrence of head pain, safety and tolerability.

Detailed description: Phase 3 Inverventional

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

Criteria:

Inclusion Criteria:

- At least a 6 month history of probably migraine (6 migraine attacks per month)

- Males and women of childbearing potential on a adequate contraception.

Exclusion Criteria:

- Physician diagnosis of migraine; history of triptan or ergot use; history of headache

prophylaxis use

- Pregnant and/or nursing mother

- History of cardiovascular disease.

- Uncontrolled hypertension.

- Basilar or Hemiplegic migraine

- History of stroke or transient ischemic attacks (TIA).

- History of epilepsy or treated with anti-epileptics within the past 5 years.

- Impaired hepatic or renal function.

- History of gastrointestinal bleeding or ulceration.

- Allergy or hypersensitivity to Aspirin or any other NSAID.

- Allergy or hypersensitivity to triptans.

- Participated in an investigational drug trial in the previous 4 weeks.

HOPE Research Institute, Phoenix, Arizona 85050, United States

Central Phoenix Medical Clinic, Phoenix, Arizona 85014, United States

Clinical Study Centers, Little Rock, Arkansas 72205, United States

NuLife Clinical Research, Inc., Anaheim, California 92805, United States

Centre for Health Care, San Diego, California 92128, United States

San Francisco Clinical Research Center, San Francisco, California 94109, United States

NuLife Clinical Research, Inc., Anaheim, California 92805, United States

Clinical Neurology and Electromyography, Newport Beach, California 92660, United States

Westlake Medical Research, Westlake Village, California 91361, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Neurological Research Institute of the East Bay, Walnut Creek, California 94596, United States

Neurological Research Institute, Santa Monica, California 90404, United States

Clinicos, Llc, Colorado Springs, Colorado 80904, United States

The New England Center for Headaches, PC, Stamford, Connecticut 06902, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Research Consultants Group, Miami, Florida 33144, United States

Neurology & Headache Specitalists of Atlanta, LCC, Decatur, Georgia 30033, United States

Georgia Clinical Research, Atlanta, Georgia 30308, United States

Neurology & Headache Specitalists of Atlanta, LCC, Decatur, Georgia 30033, United States

Diamond Headache Clinic, Chicago, Illinois 60614, United States

Oliver Headache and Pain Clinic, Evansville, Indiana 47712, United States

Heartland Research, Wichita, Kansas 67207, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States

Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan 48104, United States

Park Nicollet Health Services, Minneapolis, Minnesota 55426, United States

Mercy Health Research, St. Louis, Missouri 63141, United States

Headache Care Center, Clinvest, Inc., Springfield, Missouri 65807, United States

Radiant Research, Las Vegas, Nevada 89146, United States

Lovelace Scientific Research, Albuquerque, New Mexico 87108, United States

Braveman-Panza Medical Group, Albany, New York 12206, United States

North Shore Pain Services, LLP, Valley Stream, New York 11580, United States

University of Rochester, Rochester, New York 14642, United States

Montefiore Memorial Hospital, Bronx, New York 10461, United States

Analgesic Development Ltd., New York, New York 10022, United States

UNC Chapel Hill, Chapel Hill, North Carolina 27599, United States

Headache Wellness Center, Greensboro, North Carolina 27401, United States

Triangle Medical Research Associates, Raleigh, North Carolina 27609, United States

UNC Chapel Hill, Chapel Hill, North Carolina 27599, United States

ClinExcel Research, West Chester, Ohio 45069, United States

New Albany Surgical Hospital Foundation, Westerville, Ohio 43081, United States

The Cleveland Clinic Founcation, Cleveland, Ohio 44195, United States

Community Research, Cincinnati, Ohio 45245, United States

Community Research, Cincinnati, Ohio 45245, United States

Medford Neurological & Spine Clinic, Medford, Oregon 97504, United States

Preferred Primary Care Physicians, Pittsburg, Pennsylvania 15236, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States

Radiant Research, Anderson, South Carolina 29621, United States

Hillcrest Clinical Research, LLC, Simpsonville, South Carolina 29681, United States

Nashville Neuroscience Group, Nashville, Tennessee 37203, United States

Benchmark Research, Austin, Texas 78705, United States

Neuro, Houston, Texas 77030, United States

Bellaire Neurology, Bellaire, Texas 77401, United States

Clinical Researchers of South Texas, Katy, Texas 77450, United States

Innovative Clinical Trials, San Antonio, Texas 78229, United States

Primary Care, Austin, Texas 78745, United States

Foothill Family Clinicl South, Salt Lake City, Utah 84121, United States

Holladay Family Practice, Salt Lake City, Utah 84107, United States

Foothill Family Clinic, Salt Lake City, Utah 84109, United States

Southwest Family Medicine, West Jordan, Utah 84084, United States

Holladay Family Practice, Salt Lake, Utah 84107, United States

Alexandria Fairfax Neurology, PC, Alexandria, Virginia 22311, United States

Swedsih Medical Center, Seattle, Washington 98104, United States

Wentachee Valley Medical Center, Wenatchee, Washington 98801, United States

University of Washington Medical Center, Seattle, Washington 98105, United States

Last updated: December 18, 2007