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Completed

NCT Number: NCT00387881

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

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.

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Key information

Conditions

Migraine, Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine without Aura Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sumatriptan succinate / naproxen sodium

Drug

sumatriptan 85mg / naproxen sodium 500mg

Placebo

Drug

Placebo to match Treximet tablets

Primary outcomes

  1. Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

    Time frame: 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 outcomes

  1. Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment

    Time frame: 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.

  2. Sustained Headache Relief 2-24 Hours After Treatment

    Time frame: 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.

  3. Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment

    Time frame: 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.

  4. Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment

    Time frame: 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.

  5. Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment

    Time frame: 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.)

  6. Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours

    Time frame: 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.)

  7. Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment

    Time frame: 2 and 4 hours after treatment

    Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)

  8. Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 13, 2006
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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