Migraine Study in Adolescent Patients

Condition(s) targeted: Migraine; Migraine Headache; Migraine With or Without Aura; Migraine, Acute

Intervention: Placebo (Drug); Sumatriptan and Naproxen Sodium (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 was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Official title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: Efficacy (pain intensity as measured by scores on a 4-point rating scale)

Secondary outcome:

Migraine symptomatology (pain intensity as measured by scores on a 4-point rating scale for photo- and photophobia, nausea and rescue medication use)

Efficacy (pain intensity as measured by scores on a 4-point rating scale)

Detailed description: The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria:

1. Subject is >/=12 years of age and >/=17 years of age at the Screening Visit.

2. Subject has migraine with or without aura (ICHD-II criteria, 1. 2.1 or 1. 1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.

3. Subject is able to distinguish migraine from other headaches (i. e., tension-type headaches).

4. Male or female subjects. Female subjects are eligible for participation in the study if they are:

1. Females of non-childbearing potential; or

2. Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy

5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.

6. Subject and subject's parent or legal guardian are able to read and write English or Spanish.

7. Subject is able to read, comprehend, and complete subject diaries.

8. Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.

9. Subject is willing and able to provide Informed Assent prior to entry into the study (if required).

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Exclusion Criteria:

- Subjects meeting any of the following criteria must not be enrolled in the study:

1. Subject is < 74 pounds (33. 3 kg).

2. Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1. 4), basilar (ICHD-II 1. 2.6), or hemiplegic migraine (ICHD-II 1. 2.4), or secondary headaches.

3. Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.

4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

5. 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.

6. Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above.

7. 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.

8. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.

9. 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.

10. Subject has used an ergot medication in the previous three months for migraine prophylaxis 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.

11. Subject has a recent history of regular use of opioids or barbiturates for 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.

12. 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 two weeks prior to screening through two weeks post treatment.

13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.

14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.

15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s).

16. 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.

17. Subject has participated in any investigational drug trial within the previous 4 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, Phoenix, Arizona 85016, United States; Recruiting

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

GSK Investigational Site, Phoenix, Arizona 85013, United States; Recruiting

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

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

GSK Investigational Site, Conway, Arkansas 72034, United States; Recruiting

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

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

GSK Investigational Site, Little Rock, Arkansas 72202, United States; Recruiting

GSK Investigational Site, Fullteron, California 92835, United States; Recruiting

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

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

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

GSK Investigational Site, Sacramento, California 95815, United States; Recruiting

GSK Investigational Site, Chico, California 95926, United States; Recruiting

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

GSK Investigational Site, Huntington Beach, California 92647, United States; Recruiting

GSK Investigational Site, Sacramento, California 95816, United States; Completed

GSK Investigational Site, Roseville, California 95678, United States; Completed

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

GSK Investigational Site, Fairfield, Connecticut 06824, United States; Recruiting

GSK Investigational Site, Hialeah, Florida 33013, United States; Recruiting

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

GSK Investigational Site, Gainesville, Florida 32607, United States; Recruiting

GSK Investigational Site, Pensacola, Florida 32504, United States; Recruiting

GSK Investigational Site, Miami, Florida 33155-3009, United States; Recruiting

GSK Investigational Site, St. Cloud, Florida 34769, United States; Withdrawn

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

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

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

GSK Investigational Site, Park Ridge, Illinois 60068, United States; Recruiting

GSK Investigational Site, Chicago, Illinois 60614, United States; Recruiting

GSK Investigational Site, Oak Lawn, Illinois 60453, United States; Not yet recruiting

GSK Investigational Site, Terre Haute, Indiana 47802, United States; Recruiting

GSK Investigational Site, Anderson, Indiana 46011, United States; Completed

GSK Investigational Site, Wichita, Kansas 67207, United States; Recruiting

GSK Investigational Site, Kansas City, Kansas 66160, United States; Recruiting

GSK Investigational Site, Lexington, Kentucky 40509, United States; Recruiting

GSK Investigational Site, Bardstown, Kentucky 40004, United States; Recruiting

GSK Investigational Site, Pikesville, Maryland 21208, United States; Recruiting

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

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

GSK Investigational Site, Plymouth, Minnesota 55441, United States; Recruiting

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

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

GSK Investigational Site, Omaha, Nebraska 68130, United States; Recruiting

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

GSK Investigational Site, Willingboro, New Jersey 08046, United States; Recruiting

GSK Investigational Site, Vorhees, New Jersey 08043, United States; Recruiting

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

GSK Investigational Site, Amherst, New York 14226, United States; Recruiting

GSK Investigational Site, Mineola, New York 11501, United States; Recruiting

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

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

GSK Investigational Site, Raleigh, North Carolina 27607, United States; Recruiting

GSK Investigational Site, Westerville, Ohio 43081, United States; Recruiting

GSK Investigational Site, West Chester, Ohio 45069, United States; Recruiting

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

GSK Investigational Site, Cincinnati, Ohio 45229, United States; Recruiting

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

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

GSK Investigational Site, Salem, Oregon 97301, United States; Recruiting

GSK Investigational Site, Portland, Oregon 97210, United States; Recruiting

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

GSK Investigational Site, Philadelphia, Pennsylvania 19139, United States; Recruiting

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

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

GSK Investigational Site, Greer, South Carolina 29651, United States; Recruiting

GSK Investigational Site, Bristol, Tennessee 37620, United States; Recruiting

GSK Investigational Site, Clarksville, Tennessee 37043, United States; Recruiting

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

GSK Investigational Site, Houston, Texas 77030-2303, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75230, United States; Recruiting

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

GSK Investigational Site, Charlottesville, Virginia 22902, United States; Recruiting

GSK Investigational Site, Norfolk, Virginia 23510, United States; Recruiting

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

GSK Investigational Site, Vancouver, Washington 98686, United States; Recruiting

GSK Investigational Site, Seattle, Washington 98195-6097, United States; Not yet recruiting

GSK Investigational Site, Middleton, Wisconsin 53562-2215, United States; Recruiting

GSK Investigational Site, Madison, Wisconsin 53715, United States; Recruiting

Starting date: December 2008
Ending date: March 2010
Last updated: September 11, 2009