Clinical trial NCT00843024: Migraine Study in Adolescent Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: Migraine with or without aura
Migraine efficacy
Migraine
Migraine headache
Adolescent migraine
TREXIMET
Sumatriptan succinate
Naproxen sodium
Migraine, acute
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 589
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

   -

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.

Primary outcomes:
measure: Number of Participants Who Were Pain Free at 2 Hours Post-dose
timeFrame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Secondary outcomes:
measure: Number of Participants Sustained Pain-free From 2-24 Hours
timeFrame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Photophobia-free at 2 Hours Post-dose
timeFrame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Phonophobia-free at 2 Hours Post-dose
timeFrame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Pain-free at 1 Hour Post-dose
timeFrame: 1 hour after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Sustained Photophobia-free From 2-24 Hours
timeFrame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Sustained Phonophobia-free From 2-24 Hours
timeFrame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Sustained Nausea-free From 2-24 Hours
timeFrame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
timeFrame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
timeFrame: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
measure: Number of Participants Nausea-free at 2 Hours Post-dose
timeFrame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Other outcomes:
measure: Mean Age of Participants at Baseline Categorized by Age Group
timeFrame: Baseline
measure: Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
timeFrame: Baseline
measure: Number of Female and Male Participants Categorized by Age Group
timeFrame: Baseline
measure: Number of Participants of the Indicated Race Categorized by Age Group
timeFrame: Baseline
measure: Mean Weight of Participants at Baseline Categorized by Age Group
timeFrame: Baseline
measure: Mean Body Mass Index of Participants at Baseline Categorized by Age Group
timeFrame: Baseline
Locations:
city: Gilbert
country: United States
facility: GSK Investigational Site
state: Arizona
city: Litchfield Park
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Conway
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Chico
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fullteron
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fairfield
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oak Lawn
country: United States
facility: GSK Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: GSK Investigational Site
state: Illinois
city: Anderson
country: United States
facility: GSK Investigational Site
state: Indiana
city: Terre Haute
country: United States
facility: GSK Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Pikesville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Worcester
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Vorhees
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Amherst
country: United States
facility: GSK Investigational Site
state: New York
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: GSK Investigational Site
state: New York
city: Schenectady
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: West Chester
country: United States
facility: GSK Investigational Site
state: Ohio
city: Westerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Salem
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Middleton
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.