Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: GlaxoSmithKline
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
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.
See 1 more
Treatment Details
Interventions
- Placebo (Drug Therapy)
- Sumatriptan/Naproxen Sodium (Combination Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: arm 1Experimental Treatment1 Intervention
Treximet (sumatriptan/naproxen sodium)
Group II: arm 2Placebo Group1 Intervention
placebo to match
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteMilford, MA
GSK Investigational SiteAustin, TX
GSK Investigational SiteSan Antonio, TX
GSK Investigational SiteWenatchee, WA
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4834
Patients Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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