Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or Trexima (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329459

Enrollment

320

Registered

2006-05-24

Start date

2006-05-31

Completion date

2006-11-30

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Keywords

menstrual migraine, headache, early intervention, dysmenorrhea

Brief summary

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

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 was formerly known as TREXIMA)

Interventions

DRUGsumatriptan succinate/naproxen sodium

DRUGplacebo

placebo to match

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Score on a 4-point migraine pain scale for a single menstrual migraine attack	2 to 48 hours

Secondary

Measure	Time frame
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	from 2 to 48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026