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

Phase 3

Completed

• Conditions: Migraine, Without Aura
• Interventions: Drug: Placebo; Drug: sumatriptan succinate / naproxen sodium

• Registration Number: NCT00387881
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-19
• Results First Submitted QC: 2009-05-19
• Results First Posted: 2009-07-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 679

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Treximet	sumatriptan succinate / naproxen sodium	-

Primary Outcome Measures

Name	Time	Method
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.	2 hours through 24 hours after Treatment	Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.

Secondary Outcome Measures

Name	Time	Method
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours	1-2 and 2-4 hours after treatment	Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment	2 and 4 hours after treatment	Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)
Sustained Headache Relief 2-24 Hours After Treatment	2-24 hours after treatment	Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment	0.5, 1, and 4 hours after Treatment	Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment	0 - 24 hours after treatment	Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment	0.5, 1, 2, and 4 hours after treatment	Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment	1-2, and 2- 4 hours after treatment	Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score	0 - 24 hours after treatment	Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States