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Migraine DisordersPhase 3NCT00843024

Migraine Study in Adolescent Patients

A Phase 3 study testing Sumatriptan and Naproxen Sodium in people with Migraine Disorders, run by GlaxoSmithKline at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Migraine Disorders
What is being tested?
Sumatriptan and Naproxen Sodium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
589 participants
Where
79 sitesUnited States
Study dates
Dec 2008to Jun 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Subject is < 74 pounds (33.3 kg).
  • 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.
  • Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
  • Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
  • 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.
Show all 18Show fewer
  • 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.
  • 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.
  • Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
  • 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.
  • 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.
  • 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.
  • 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.
  • Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
  • 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.
  • Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s).
  • 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.
  • 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.

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Amherst, New York, 14226

  • GSK Investigational Site

    Anderson, Indiana, 46011

  • GSK Investigational Site

    Ann Arbor, Michigan, 48104

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Chicago, Illinois, 60642

  • GSK Investigational Site

    Chico, California, 95926

  • GSK Investigational Site

    Cincinnati, Ohio, 45229

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Conway, Arkansas, 72034

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Fairfield, Connecticut, 06824

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fullteron, California, 92835

  • GSK Investigational Site

    Gainesville, Florida, 32607

  • GSK Investigational Site

    Gilbert, Arizona, 85234

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Hialeah, Florida, 33010

  • GSK Investigational Site

    Houston, Texas, 77030-2303

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Little Rock, Arkansas, 72202

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Madison, Wisconsin, 53715

  • GSK Investigational Site

    Miami, Florida, 33155-3009

  • GSK Investigational Site

    Middleton, Wisconsin, 53562-2215

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Mount Vernon, New York, 10550

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    Norfolk, Virginia, 23510

  • GSK Investigational Site

    Oak Lawn, Illinois, 60453

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Omaha, Nebraska, 68130

  • GSK Investigational Site

    Park Ridge, Illinois, 60068

  • GSK Investigational Site

    Pensacola, Florida, 32504

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19139

  • GSK Investigational Site

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Phoenix, Arizona, 85014

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Pikesville, Maryland, 21208

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Roseville, California, 95678

  • GSK Investigational Site

    Sacramento, California, 95815

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Salem, Oregon, 97301

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Schenectady, New York, 12308

  • GSK Investigational Site

    Seattle, Washington, 98195-6097

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Terre Haute, Indiana, 47802

  • GSK Investigational Site

    Vancouver, Washington, 98686

  • GSK Investigational Site

    Vorhees, New Jersey, 08043

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Chester, Ohio, 45069

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Westerville, Ohio, 43081

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Willingboro, New Jersey, 08046

  • GSK Investigational Site

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Sumatriptan and Naproxen Sodium, Placebo
Keywords
Migraine with or without aura, Migraine efficacy, Migraine, Migraine headache, Adolescent migraine, TREXIMET, Sumatriptan succinate, Naproxen sodium, Migraine, acute
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sumatriptan and Naproxen SodiumDrug

    Sumatriptan succinate and naproxen sodium

  • PlaceboDrug

    Placebo to match

Study groups in NCT00843024
Study groupRoleWhat they receive
Sumatriptan and Naproxen 1ExperimentalSumatriptan succinate and naproxen sodium combination 10mg/60mg
Receives: Drug: Sumatriptan and Naproxen Sodium
Sumatriptan and Naproxen 2ExperimentalSumatriptan succinate and naproxen sodium combination 30mg/180mg
Receives: Drug: Sumatriptan and Naproxen Sodium
Sumatriptan and Naproxen 3ExperimentalSumatriptan succinate and naproxen sodium combination 85mg/500mg
Receives: Drug: Sumatriptan and Naproxen Sodium
PlaceboPlacebo comparatorPlacebo to match
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Were Pain Free at 2 Hours Post-dose

    Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.

    Measured: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

Secondary outcomes (10)

  1. Number of Participants Sustained Pain-free From 2-24 Hours

    Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.

    Measured: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  2. Number of Participants Photophobia-free at 2 Hours Post-dose

    The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.

    Measured: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

  3. Number of Participants Phonophobia-free at 2 Hours Post-dose

    The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.

    Measured: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

  4. Number of Participants Pain-free at 1 Hour Post-dose

    Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.

    Measured: 1 hour after single dose of double-blind treatment (Randomization through Week 13)

  5. Number of Participants Sustained Photophobia-free From 2-24 Hours

    Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.

    Measured: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  6. Number of Participants Sustained Phonophobia-free From 2-24 Hours

    Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.

    Measured: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  7. Number of Participants Sustained Nausea-free From 2-24 Hours

    Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.

    Measured: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  8. Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose

    Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.

    Measured: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  9. Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points

    Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.

    Measured: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

  10. Number of Participants Nausea-free at 2 Hours Post-dose

    The number of participants who did not have nausea at 2 hours post dose was analzyed.

    Measured: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00843024
Sponsor's protocol ID
107979
Status last verified
Nov 2016
First submitted
12 Feb 2009
Last updated
18 Jan 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 17405970

  • 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.

    PubMed 22585767

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sumatriptan and Naproxen Sodium in people with Migraine Disorders, run by GlaxoSmithKline at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Were Pain Free at 2 Hours Post-dose (time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00843024, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.

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