Official Title: “Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents”

This study was designed to determine long-term safety of TREXIMA compared to placebo for the treatment of acute migraine.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: August 2009

This study was designed to determine long-term safety of TREXIMA compared to placebo for the treatment of acute migraine.

Intervention(s) in this Clinical Trial

• Drug: Combination Product (sumatriptan succinate / naproxen sodium)
  • Drug: (sumatriptan/naproxen sodium)

Primary Measures

• Safety data (adverse events, laboratory and ECG changes, and vital signs) will be summarized. Data will be collected at Screen, every 3 months, through 12 months.
  • Time Frame: 0 - 6 mos; 6 -12 mos
    Safety Issue?: Yes

Secondary Measures

• Efficacy and migraine symptomatology will be secondary. Data will collected daily.
  • Time Frame: 0 - 6 mons; 6 -12 mos; 0 - 12 mos
    Safety Issue?: Yes

Inclusion Criteria:

• Subject is between 12 and 17 years old at the Screening visit.
• If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate <1% or abstinence) if she is/becomes sexually active.
• Subject has migraine with or without aura (2004 ICHD-II criteria).
• Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated).
• Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit.
• Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
• Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
• Subject and subject's parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study.
• Subject and subject's parent or legal guardian are able to read and write English or Spanish.
• Subject is able to understand and complete the electronic device to report treatment information.

Exclusion Criteria:

• Subject is < 75 pounds (33.3kg).
• Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1).
• Subject has uncontrolled hypertension (See Appendix 2, section 11.2) 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.
• Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's
• Syndrome, 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 is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; 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 his/her 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 2 weeks prior to screening through 2 weeks post final study treatment.
• Subject 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 or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
• 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 an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

Clinical Trials GlaxoSmithKline Study Chair GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00488514

Study ID Number: TXA107977

ClinicalTrials.gov Identifier: NCT00488514

Health Authority: United States: Food and Drug Administration