Full Text View
Tabular View
No Study Results Posted
Related Studies
Long-Term Safety of Trexima for Migraine in Adolescents
This study is ongoing, but not recruiting participants.
First Received: June 18, 2007   Last Updated: August 19, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00488514
  Purpose

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


Condition Intervention Phase
Migraine
Drug: Combination Product (sumatriptan succinate / naproxen sodium)
Phase III

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and migraine symptomatology will be secondary. Data will collected daily. [ Time Frame: 0 - 6 mons; 6 -12 mos; 0 - 12 mos ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: June 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Combination Product (sumatriptan succinate / naproxen sodium)
    Drug: (sumatriptan/naproxen sodium)
Detailed Description:

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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488514

  Show 84 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: Clinical Trials GlaxoSmithKline GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Frederick Derosier, DO )
Study ID Numbers: TXA107977
Study First Received: June 18, 2007
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00488514     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Migraine
Adolescent Migraine Headache
Long-term Safety
sumatriptan succinate
naproxen sodium

Additional relevant MeSH terms:
Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Headache Disorders, Primary
Brain Diseases
Gout Suppressants
Headache Disorders
Sensory System Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen
Nervous System Diseases
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Sumatriptan
Serotonin Agents
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009