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Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: May 22, 2006
Last updated: April 15, 2015
Last verified: April 2015
This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

Condition Intervention Phase
Migraine Disorders
Drug: sumatriptan succinate/naproxen sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: May 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:
A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
  • Typically experiences moderate to severe migraine pain preceded by a mild pain phase
  • Differentiate between mild migraine pain and other headache types
  • Women of childbearing potential must be on adequate contraception

Exclusion Criteria:

  • Pregnant and/or nursing mother
  • History of cardiovascular disease
  • Uncontrolled hypertension
  • Basilar or Hemiplegic migraine
  • History of stroke or transient ischemic attacks (TIA)
  • History of epilepsy or treated with anti-epileptics within past 5 years
  • Impaired hepatic or renal function
  • History of gastrointestinal bleeding or ulceration
  • Allergy or hypersensitivity to aspirin or any other NSAID
  • Allergy or hypersensitivity to triptans
  • Participated in an investigational drug trial in the previous 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00329355

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00329355     History of Changes
Other Study ID Numbers: TRX105852 
Study First Received: May 22, 2006
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
menstrual migraine
early intervention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents processed this record on October 21, 2016