Last updated: 11/04/2018 12:58:46
Study Of Treximet, formerly known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for Trexima* (sumatriptan 85mg/naproxen sodium 500mg) administered during the mild pain phase for the acute treatment of multiple migraine attacks (*Treximet)
Trial description: The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of participants who experience sustained pain free response from 2 to 24 hours after treatment during the mild pain phase of each attack (TREXIMA vs. placebo).
Timeframe: Up to 24 hours after attack
Percentage of participants who became pain free (headache grade 0) at 2 hours after treatment during the mild pain phase of each attack (TREXIMA vs. placebo).
Timeframe: Up to 2 hours after attack
Secondary outcomes:
Percentage of participants who were treated with Trexima and demonstrate consistency of response after treatment in at least 1 of the first 2 attacks
Timeframe: Up to 2 hours after attack
Percentage of participants who were treated with Trexima and demonstrate consistency of response after treatment in at least 1 of 2 attacks, 2 of 3 attacks, 3 of 4 attacks and 4 of 4 attacks.
Timeframe: Up to 2 hours after attack
Percentage of participants who become pain free 2 hours after treatment in all attacks treated.
Timeframe: Up to 2 hours after attack
Percentage of participants who become pain free 2 hours after treatment of any attack.
Timeframe: Up to 2 hours after attack
Of the participants who become pain free (headache grade 0) 2 hours after treatment of attack 1, the percentage of participants who become pain free (headache grade 0) 2 hours after treatment of the next attack treated with TREXIMA.
Timeframe: Up to 2 hours after attack
Of the participants who fail to who become pain free (headache grade 0) 2 hours after treatment of attack 1, the percentage of participants who become pain free (headache grade 0) 2 hours after treatment of the next attack treated with TREXIMA.
Timeframe: Up to 2 hours after attack
Percentage of participants who become headache pain free at 30 minutes, 1, 3, and 4 hours after treatment.
Timeframe: Up to 4 hours after attack
Percentage of participants with nausea, photophobia, and phonophobia at 2 and 4 hours after treatment.
Timeframe: Up to 24 hours after attack
Percentage of participants who, after becoming headache pain free at 2 hours, have a return of headache pain 2-24 hours after treatment.
Timeframe: Up to 24 hours after attack
Percentage of participants migraine free (a composite endpoint free from pain, nausea, vomiting, photophobia, and phonophobia) at 2 and 4 hours after treatment.
Timeframe: Up to 4 hours after attack
Percentage of participants with relief of neck pain/discomfort at 2, 4 and 6 hours after treatment
Timeframe: Up to 6 hours after attack
Percentage of participants with relief of sinus pain/pressure at 2, 4 and 6 hours after treatment
Timeframe: Up to 6 hours after attack
Percentage of participants satisfied with treatment measured by the Patient Perception of Migraine Questionnaire-Revised (PPMQ-R) 24 hours after treatment.
Timeframe: Up to 24 hours after attack
Number of participants with adverse events (AEs), serious adverse events (SAEs) and intensity of AEs
Timeframe: Up to 4 months
Percentage of participants with attacks that become pain free at 2 hours after treatment with investigational product
Timeframe: Up to 2 hours after attack
Percentage of participants with sustained migraine free from 2 to 24 hours after treatment.
Timeframe: Up to 24 hours after attack
Interventions:
Enrollment:
623
Primary completion date:
2006-07-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13.
Lipton RB, Dodick DW, Adelman JU, Kaniecki RG, Lener SE, White JD, Nelsen AC. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. Cephalalgia 2009; 29, 826–836 (doi:10.1111/j.1468-2982.2008.01806.x).
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
October 2005 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- 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.
- Pregnant and/or nursing mother.
- History of cardiovascular disease.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Study Complete
Showing 1 - 6 of 52 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-07-06
Actual study completion date
2006-07-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
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.
Click hereAccess to clinical trial data by researchers
Visit website