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

• ClinicalTrials.gov Identifier: NCT00329459
• Recruitment Status: Completed
• First Posted: May 24, 2006
• Last Update Posted: October 24, 2016
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: May 22, 2006
• First Posted Date: May 24, 2006
• Last Update Posted Date: October 24, 2016
• Study Start Date: May 2006
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 23, 2010): Score on a 4-point migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ]
• Original Primary Outcome Measures (submitted: May 22, 2006): Score on a migraine pain scale at 2 hours through 48 hours for a single menstrual migraine attack
• Current Secondary Outcome Measures (submitted: September 23, 2010): 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: from 2 to 48 hours ]

Original Secondary Outcome Measures (submitted: May 22, 2006)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
• Official Title: 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
• 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)
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Migraine Disorders

Intervention

• Drug: sumatriptan succinate/naproxen sodium
• Drug: placebo
  placebo to match

Study Arms

• Experimental: arm 1
  Treximet (sumatriptan/naproxen sodium)
  Intervention: Drug: sumatriptan succinate/naproxen sodium
• Placebo Comparator: arm 2
  placebo to match
  Intervention: Drug: placebo

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):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.
• Martin VT, Ballard J, Diamond MP, Mannix LK, Derosier FJ, Lener SE, Krishen A, McDonald SA. Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. J Womens Health (Larchmt). 2014 May;23(5):389-96. doi: 10.1089/jwh.2013.4577. Epub 2014 Feb 28.
• Cady RK, Diamond ML, Diamond MP, Ballard JE, Lener ME, Dorner DP, Derosier FJ, McDonald SA, White J, Runken MC. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 22, 2006): 320
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2006
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00329459
• Other Study ID Numbers: TRX105850
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Not Provided
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: October 2016