Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00329355

First received: May 22, 2006

Last updated: January 20, 2017

Last verified: January 2017

History of Changes

Purpose

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 Migraine Disorders	Drug: sumatriptan succinate/naproxen sodium	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation Migraine

Drug Information available for: Succinic acid Naproxen Naproxen sodium Sumatriptan Sumatriptan succinate

U.S. FDA Resources

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 ]

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 ]


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)

Eligibility


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

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
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 ClinicalTrials.gov identifier: NCT00329355

Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.

Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.

Study Data/Documents: Annotated Case Report Form This link exits the ClinicalTrials.gov site