TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Migraine, Without Aura

Treatments: Drug: sumatriptan succinate / naproxen sodium; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387881

TXA107563

Details and patient eligibility

About

This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Enrollment: 679 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least a 6 month history of probably migraine (6 migraine attacks per month)
• Males and women of childbearing potential on a adequate contraception.

Exclusion criteria

• Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
• 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 the 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

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679 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Treximet

Experimental group

Treatment:

Drug: sumatriptan succinate / naproxen sodium