Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders; Migraine

Treatments: Drug: sumatriptan succinate/naproxen sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329355

TRX105852

Details and patient eligibility

About

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.

Full 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)

Enrollment: 351 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind