Phase 4
Completed N=147
"Completeness of Response" Following Treatment With Treximet™ for Migraine
Source: ClinicalTrials.gov NCT00893737 ↗Enrolled (actual)
147
Serious AEs
1.4%
Results posted
Jan 2011
Primary outcomePrimary: Change in Scores From Completeness of Response Survey (CORS) — 0.17; 0.07; 0.03; 0.10 Units on a scale
Summary
Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2 visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2 considering their study medication (Treximet™).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Scores From Completeness of Response Survey (CORS) |
0.17; 0.07; 0.03; 0.10 | — |
| SECONDARY Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan |
42; 52; 43; 42; 45; 36 | — |
| SECONDARY Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R) |
8.61; 13.86; 2.76; 7.28 | — |
Eligibility Criteria
Inclusion Criteria
Subject must be/have
- age 18 to 65
- able to read, understand, and sign informed consent
- willing to record migraine headaches and response to treatment in diary
- diagnosis of migraine headache (IHS 1.1 or 1.2), without and/or with aura
- at least one year history of migraine
- 3-8 attacks per month in past 3 months
- onset of migraine before age 50
- current triptan user (treated with triptan as primary migraine therapy at least 2 times per month in 3 months prior to screening)
- history of migraine starting at mild pain for at least 75% of migraine attacks
- use reliable method of birth control if female and childbearing potential (i.e. reliable barrier method, oral contraceptive, implant, contraceptive patch, long term injectable contraceptive, intrauterine device or tubal ligation)
- on stabilized dosages of current concomitant medications at least 90 days (may include migraine preventive medications), and willing to continue during study period
Exclusion Criteria
Subject has/is
- history of serotonin syndrome
- medical condition that, in opinion of the investigator, could confound results of the study
- female of childbearing potential not using adequate contraceptive measures
- 15 or more headache days per month in total, or history of retinal,, basilar or hemiplegic migraine, cluster headache, or secondary headaches (such as due to trauma, infection, alterations of homeostasis, ENT or psychiatric disorders, cranial or cervical disorders or neuralgias)
- in investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, or family history of coronary artery disease)
- blood pressure ≥ 140/90 mmHg in 2 of 3 BP measurements at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
- a history of congenital heart disease, cardiac arrhythmias requiring medication, or history of clinically significant electrocardiogram abnormality that, in investigator's opinion, contraindicates participation in this study
- evidence or history of ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of above
- evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower convulsive threshold; or has been treated with antiepileptic drug for seizure control within 5 years prior to screening
- history of impaired hepatic or renal function that, in investigator's opinion, contraindicates participation in study
- hypersensitivity, intolerance, or contraindication to use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma
- currently taking, or has taken in previous three months, migraine prophylactic medication containing methysergide; or is taking migraine or menstrual migraine prophylactic medication that is not stabilized (i.e., change of dose within the past 2 months)
- recent history of regular use of opioids or barbiturates for treatment of migraine headache and/or other non-migraine pain (regular use defined as an average of 4 days per month over last 6 months)
- taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within 2 weeks prior to screening through 2 weeks post final study treatment
- history of any bleeding disorder or is currently taking anti-coagulant or antiplatelet agent
- evidence or history of gastrointestinal surgery or GI ulceration or perforation in past six months, gastrointestinal bleeding in past year; or evidence or history of inflammatory bowel disease
- pregnant, actively trying to bec
Data sourced from ClinicalTrials.gov (NCT00893737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.