"Completeness of Response" Following Treatment With Treximet™ for Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00893737
• Date of registration: 05/05/2009
• Primary sponsor: Cady, Roger, M.D.
• Public title: "Completeness of Response" Following Treatment With Treximet™ for Migraine
• Scientific title: An Open-label Study to Evaluate "Completeness of Response" Following Treatment With Treximet™ for Migraine
• Date of first enrolment: June 2009
• Target sample size: 147
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00893737
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Roger K Cady, MD
• Affiliation: Clinvest

Key inclusion & exclusion 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 become pregnant, or breast feeding

- evidence of alcohol or substance abuse within last year or any concurrent medical or
psychiatric condition which, in investigator's judgment, will likely interfere with
study conduct, subject cooperation, or evaluation and interpretation of study
results, or which otherwise contraindicates participation in this clinical trial

- participated in an investigational drug trial within previous four weeks or plans to
participate in another study at any time during this study



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine

Intervention(s)

Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)

Primary Outcome(s)

Change in Scores From Completeness of Response Survey (CORS) [Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)]

Secondary Outcome(s)

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) [Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)]

Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan [Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)]

Secondary ID(s)

110211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline