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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

  Hide Study Locations
Locations
United States, Arizona
Valley Neurological Headache and Research Center
Phoenix, Arizona, United States, 85014
Neurological Physicians of Arizona, Inc.
Gilbert, Arizona, United States, 85234
United States, Arkansas
Pediatric Neurology The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States, 72401
Clinical Study Centers
Little Rock, Arkansas, United States, 72205
United States, California
Med Investigations
Fair Oaks, California, United States, 95628
Kratzer-Graves Pediatrics
Fresno, California, United States, 93720
Stephen Forner, MD
Chico, California, United States, 95926
San Francisco Clinical Research Center and Headache Clinic
San Francisco, California, United States, 94109
UCSDn Stroke Center
San Diego, California, United States, 92103
Fullerton Neurology and Headache
Fullerton, California, United States, 92835
California Medical Clinic for Headaches
Santa Monica, California, United States, 90404
Irvine Center for Clinical Research Inc.
Irvine, California, United States, 92618
Philip O'Carroll MD Inc.
Newport Beach, California, United States, 92660
Pediatric Care
Huntington, California, United States, 92647
South Bay Neurology Research Center
Redondo Beach, California, United States, 90277
Socklov Medical Research
Sacramento, California, United States, 95825
Neurological Research Institute of the East Bay
Walnut Creek, California, United States, 94596
Adult and Child Neurology
Roseville, California, United States, 95678
Northridge Neurological Center
Northridge, California, United States, 91325
Mark S. Wallace, MD
La Jolla, California, United States, 92037
United States, Colorado
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80909
The Children's Hospital - Denver Neurology
Denver, Colorado, United States, 80218
United States, Connecticut
Hartford Headache Center
Ridgfield, Connecticut, United States, 06877
Associated Neurologist of Southern Connecticut
Fairfield, Connecticut, United States, 06824
United States, Florida
Anchor Reserach A Division of Anchor Health Centers
Naples, Florida, United States, 72401
Suncoast Medical Group
St. Petersburg, Florida, United States, 33701
Suncoast Medical
St. Petersberg, Florida, United States, 33701
Pediatric Neurology and Epilepsy Center
Loxahatchee, Florida, United States, 33470
Child Neurology Clinic
Pensacola, Florida, United States, 32504
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Savannah Neurology, PC
Savannah, Georgia, United States, 31405
Child Neurology Associates, P.C.
Atlanta, Georgia, United States, 30342
United States, Idaho
Pediatric Neurology of Idaho
Boise, Idaho, United States, 83712
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
United States, Kansas
Vince & Associates
Overland Park, Kansas, United States, 66212
United States, Kentucky
CNS Associates, Inc.
Murray, Kentucky, United States, 42071
Kentucky Pediatric/Adult Relationship
Bardstown, Kentucky, United States, 40004
United States, Maryland
Child and Adolescent Neurology
Bethesda, Maryland, United States, 20817
United States, Michigan
ProMed Pediatrics
Protage, Michigan, United States, 49024
Women's Health Care Specialists, P.C.
Paw Paw, Michigan, United States, 49079
ProMed Pediatrics
Kalamazoo, Michigan, United States, 97210
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
Borgess Research Institute
Kalamazoo, Michigan, United States, 49043
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Mercy Health Research Ryan Headache Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, United States, 68130
United States, Nevada
Lovelace Scientific Resources, Inc.
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Childrens Neurology
Morristown, New Jersey, United States, 07960
Pediatric Clinical Research Center
New Brunswick, New Jersey, United States, 08901
The Center for Neurological & Neurodevelopmental Health Clinical Research Center of New Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Braverman-Panza Medical Group
Albany, New York, United States, 12206
Rochester Clinical Research
Rochester, New York, United States, 14609
University of Rochester
Rochester, New York, United States, 14642
Gosy & Associates Pain Treatment and Neurology, LLP
Williamsville, New York, United States, 14221
The Elkind Headache Clinic
Mt Vernon, New York, United States, 10550
Neurology Group of Bergen County, P. A.
Ridgewood, New York, United States, 07450
Dent Neurologic Institute
Amherst, New York, United States, 14226
Analgesic Development Ltd.
New York, New York, United States, 10022
Regional Clinical Research
Endwell, New York, United States, 13760
Island Neurological Associates
Plainview, New York, United States, 11803
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
OrthoNeuro
Westerville, Ohio, United States, 43018
Childrens Hospital
Columbus, Ohio, United States, 43018
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Lynn Health Science Institute
Oklahama City, Oklahoma, United States, 73112
United States, Oregon
Pacific Women's Center
Eugene, Oregon, United States, 97401
Medford Neurologic Spine Center
Medford, Oregon, United States, 97504
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States, 97210
United States, South Carolina
Mountain View Clinical Research
Greer, South Carolina, United States, 29349
United States, Tennessee
Nashville Neurosciences Group
Nashville, Tennessee, United States, 37203
United States, Texas
Neurology, Headache & Pain Control Center
Nassau Bay, Texas, United States, 77058
Texas Child Neurology
Plano, Texas, United States, 75075
Radiant Research
San Antonio, Texas, United States, 78229
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230-2507
Georgetown Medical Center Clinic
Georgetown, Texas, United States, 78628
United States, Utah
Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
J. Lewis Research, Inc.
Salt Lake City, Utah, United States, 84109
United States, Virginia
Monarch Medical Research
Norfolk, Virginia, United States, 23510
Pedeatric Research of Charlottesville, LLC
Charolottesville, Virginia, United States, 22902
United States, Washington
Kitsap Center for Clinical Studies
Bremerton, Washington, United States, 98310
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
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 27, 2009