Migraine Study in Adolescent Patients

NCT ID: NCT00843024

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 589 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-06-30

Brief Summary

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

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.

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sumatriptan and Naproxen 1

Sumatriptan succinate and naproxen sodium combination 10mg/60mg

Group Type: EXPERIMENTAL

Sumatriptan and Naproxen Sodium

Intervention Type: DRUG

Sumatriptan succinate and naproxen sodium

Sumatriptan and Naproxen 2

Sumatriptan succinate and naproxen sodium combination 30mg/180mg

Group Type: EXPERIMENTAL

Sumatriptan and Naproxen Sodium

Intervention Type: DRUG

Sumatriptan succinate and naproxen sodium

Sumatriptan and Naproxen 3

Sumatriptan succinate and naproxen sodium combination 85mg/500mg

Group Type: EXPERIMENTAL

Sumatriptan and Naproxen Sodium

Intervention Type: DRUG

Sumatriptan succinate and naproxen sodium

Placebo

Placebo to match

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match

Interventions

Sumatriptan and Naproxen Sodium

Sumatriptan succinate and naproxen sodium

Intervention Type: DRUG

Placebo

Placebo to match

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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).

-

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Gilbert, Arizona, United States

GSK Investigational Site

Litchfield Park, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Conway, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Chico, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Fullteron, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Fairfield, Connecticut, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Oak Lawn, Illinois, United States

GSK Investigational Site

Park Ridge, Illinois, United States

GSK Investigational Site

Anderson, Indiana, United States

GSK Investigational Site

Terre Haute, Indiana, United States

GSK Investigational Site

Kansas City, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Pikesville, Maryland, United States

GSK Investigational Site

Worcester, Massachusetts, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Vorhees, New Jersey, United States

GSK Investigational Site

Willingboro, New Jersey, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Amherst, New York, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

Mount Vernon, New York, United States

GSK Investigational Site

Schenectady, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

West Chester, Ohio, United States

GSK Investigational Site

Westerville, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Salem, Oregon, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Greer, South Carolina, United States

GSK Investigational Site

Simpsonville, South Carolina, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Clarksville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Vancouver, Washington, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Middleton, Wisconsin, United States

Countries

United States

References

Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.

Reference Type: BACKGROUND

PMID: 17405970 (View on PubMed)

Derosier FJ, Lewis D, Hershey AD, Winner PK, Pearlman E, Rothner AD, Linder SL, Goodman DK, Jimenez TB, Granberry WK, Runken MC. Randomized trial of sumatriptan and naproxen sodium combination in adolescent migraine. Pediatrics. 2012 Jun;129(6):e1411-20. doi: 10.1542/peds.2011-2455. Epub 2012 May 14.

Reference Type: DERIVED

PMID: 22585767 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

107979

Identifier Type: -

Identifier Source: org_study_id