Treximet Early Intervention Adolescent Migraine (TEAM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Premiere Research Institute
ClinicalTrials.gov Identifier:
NCT01016678
First received: November 18, 2009
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.


Condition Intervention Phase
Adolescent Migraine
Drug: Treximet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Resource links provided by NLM:


Further study details as provided by Premiere Research Institute:

Primary Outcome Measures:
  • Treatment comparisons between TREXIMET and placebo will be used to support the conclusions of consistency of response to TREXIMET across attacks. The primary parameters of interest are the 2-hour pain free and 24 hour sustained pain free. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All related symptoms and use of rescue medications will be analyzed for secondary outcome measures. Patient safety will be analyzed as well. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 105
Study Start Date: March 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active, Active, Active, Placebo
One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo.
Drug: Treximet
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
Active, Active, Placebo, Active
This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet.
Drug: Treximet
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
Active, Placebo, Active, Active
Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug.
Drug: Treximet
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
Placebo, Active, Active, Active
One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet.
Drug: Treximet
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
Active, Active, Active, Active
One fifth of the subject will treat all their migraines with Active Treximet.
Drug: Treximet
85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

Detailed Description:

There are two primary treatment comparisons for this study: 1) the percentage of subjects' pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET versus placebo across attacks.

The following alternative hypothesis will be tested to see if there is a difference in the proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all attacks, OR there is a difference in the proportion of subjects who are sustained pain free at 24 hours with TREXIMET versus placebo at all attacks.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects between the ages of 12-17.
  2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit. Attacks should be moderate to severe and last for at least 3 hours.
  3. Subject is able to distinguish migraine from other headaches and can determine when a mild headache will become a moderate/severe migraine.
  4. Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception.
  5. Subject and subject's parent or legal guardian are able to read and write English.
  6. Subject is able to read, comprehend, and complete subject diaries.
  7. Subjects' parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.
  8. Subject is willing and able to provide Informed Assent prior to entry into the study.

Exclusion Criteria

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

  1. Subject is < 74 pounds (33.3kg) and no greater than 260lbs (117.9kg)
  2. Subject has greater than or equal to 15 headache days per month in total.
  3. Subject has secondary headaches i.e. complex migraine, hemiplegic, or basilar.
  4. Subject, in investigators opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
  5. Subject has uncontrolled hypertension at screening or is taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
  6. 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 the study.
  7. 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 the above.
  8. Subject has a 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 anti-epileptic drug for seizure control within 5 years prior to screening.
  9. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
  10. Subject has a hypersensitivity, allergy, intolerance, or contraindication to the use any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps or asthma.
  11. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized for at least two months for either chronic or intermittent migraine prophylaxis or other co-morbid condition.
  12. Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. Johns Wort (Hypericum perforatum), anytime within the two weeks prior to screening and two weeks past exit of study.
  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 has evidence of illicit drug or alcohol abuse within the last year or any concurrent psychiatric condition which, in the investigator's opinion, will likely interfere with study conduct and participation in the 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016678

Locations
United States, Florida
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Ohio
Andrew Hershey
Cincinnati, Ohio, United States, 45229
United States, Texas
Steve L. Linder
Dallas, Texas, United States, 75230
United States, Virginia
Don W. Lewis
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Premiere Research Institute
GlaxoSmithKline
Investigators
Principal Investigator: Paul K Winner, DO Premiere Research Institute
Principal Investigator: Andrew Hershey, MD Cincinnati Childrens Hospital
Principal Investigator: Steve L Linder, MD Dallas Pediatric Neurology Associates
Principal Investigator: Donald W Lewis, MD Childrens Hospital of the King's Daughters
  More Information

No publications provided

Responsible Party: Premiere Research Institute
ClinicalTrials.gov Identifier: NCT01016678     History of Changes
Other Study ID Numbers: TEAM2009
Study First Received: November 18, 2009
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014