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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)

Conditions
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Migraine, Without Aura

Intervention / Treatment
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* Drug: sumatriptan succinate / naproxen sodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to match Treximet tablets<br>|
| Experimental: Treximet<br> | Drug: sumatriptan succinate / naproxen sodium<br>* sumatriptan 85mg / naproxen sodium 500mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | 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. | 2 hours through 24 hours after Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Headache Pain at 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. | 0.5, 1, and 4 hours after Treatment | 
| Sustained Headache Relief 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. | 2-24 hours after treatment | 
| Headache Relief at 4, 2, 1 and 0.5 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. | 0.5, 1, 2, and 4 hours after treatment | 
| Subjects Who Used Rescue Medication From 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. | 0 - 24 hours after treatment | 
| Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 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.) | 1-2, and 2- 4 hours after treatment | 
| Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | 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.) | 1-2 and 2-4 hours after treatment | 
| Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.) | 2 and 4 hours after treatment | 
| Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | 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. | 0 - 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sumatriptan succinate,, naproxen sodium,, parallel group,, double-blind,, placebo-controlled,, Combination product,, migrainous headache, Probable migraine, a sub-type of Migraine, probable migraine,