MigrainePhase 4NCT00893737
"Completeness of Response" Following Treatment With Treximet™ for Migraine
A Phase 4 study testing sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) in people with Migraine, run by Cady, Roger, M.D. at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Wesley Headache Clinic and Research Center
Cordova, Tennessee, 38018
Westside Family Medical Center
Kalamazoo, Michigan, 49009
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236
Island Neurological Associates, PC
Plainview, New York, 11803
Texas Headache Associates
San Antonio, Texas, 78258
San Francisco Clinical Research Center
San Francisco, California, 94109
Clinvest
Springfield, Missouri, 65807
Mercy Health Research/Ryan Headache Center
St Louis, Missouri, 63141
About this study
Official title: An Open-label Study to Evaluate "Completeness of Response" Following Treatment With Treximet™ for Migraine
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™).
Read the detailed description
At the screening visit (Visit 1), following written informed consent, subjects will provide a medical, medication and migraine history. A physical and neurological exam and pregnancy test (if appropriate) will be performed. Vital signs will be recorded for all subjects. The Headache Impact Test (HIT-6) and Baseline Patient Perception of Migraine Questionnaire (PPMQ-R) will be completed with the Baseline Completeness of Response Survey (CORS) considering migraine therapy (triptan) utilized during the 3 months prior to enrollment. The Completeness of Response Survey will collect traditional and non-traditional symptoms. Subjects are instructed to treat all migraines that occur in the next 2 months. Subjects will treat with a single tablet of Treximet™ as soon as they have a headache indicative of migraine and are encouraged to treat when the headache is mild. A Headache Diary documenting onset of headache pain and associated symptoms, time of treatment with study medication, symptoms at 2 hours following treatment, time of relief, recurrence of symptoms within 24 hours post-treatment, and adverse events will be dispensed with study medication. Subjects may take a 2nd dose of study medication or medication determined by the investigator for rescue of persistent or recurring headache at 2 or more hours following the 1st dose of study medication. Alternate rescue medication can be provided at the discretion of the investigator but may not include triptan, non-steroidal anti-inflammatory (short-acting NSAID between 6 hours before and 2 hours after study medication or long-acting NSAID between 24 hours before and 24 hours after study medication), or ergotamine-containing or ergot-type medication. Subjects must be headache-free for 24 hours before recording the onset of a "new" migraine attack. The study coordinator will contact subjects at Month 1 to verify treatment and diary compliance.
At Visit 2, following 2 months of treatment with Treximet™, the subject will return to the study site and return completed Headache Diaries. The End of Study CORS, CORS Comparator and End of Study PPMQ-R will be completed considering response with study medication. Adverse events will be documented and Diaries and Questionnaires will be reviewed.
- Conditions
- Migraine
- Being tested
- sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
- Keywords
- Migraine, Headache, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)Drug
Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treximet | Experimental | Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period. Receives: Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scores From Completeness of Response Survey (CORS)
CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.
The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication).
Measured: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Secondary outcomes (2)
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.
Measured: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
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)
Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.
Measured: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Investigators
- Roger K Cady, MD, Principal investigator, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893737
- Sponsor's protocol ID
- 110211
- Status last verified
- Jan 2011
- First submitted
- 5 May 2009
- Last updated
- 25 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005 Sep;45(8):983-91. doi: 10.1111/j.1526-4610.2005.05178.x.
PubMed 16109111Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
PubMed 17405970Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62. doi: 10.1212/wnl.55.6.754. No abstract available.
PubMed 10993991Cady R, Banks J, Nett RB, Goldstein J, Bennett N, Turner IM, Ruoff GE, Landy SH, Farmer K, Juhasz M, Tarrasch J, Runken MC. Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey. Headache. 2011 Jun;51(6):961-70. doi: 10.1111/j.1526-4610.2011.01912.x. Epub 2011 May 17.
PubMed 21592098
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate "Completeness of Response" Following Treatment With Treximet™ for Migraine
- ClinicalTrials.gov ID
- NCT00893737
- Acronym / sponsor ID
- 110211
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™).
Detailed description
At the screening visit (Visit 1), following written informed consent, subjects will provide a medical, medication and migraine history. A physical and neurological exam and pregnancy test (if appropriate) will be performed. Vital signs will be recorded for all subjects. The Headache Impact Test (HIT-6) and Baseline Patient Perception of Migraine Questionnaire (PPMQ-R) will be completed with the Baseline Completeness of Response Survey (CORS) considering migraine therapy (triptan) utilized during the 3 months prior to enrollment. The Completeness of Response Survey will collect traditional and non-traditional symptoms. Subjects are instructed to treat all migraines that occur in the next 2 months. Subjects will treat with a single tablet of Treximet™ as soon as they have a headache indicative of migraine and are encouraged to treat when the headache is mild. A Headache Diary documenting onset of headache pain and associated symptoms, time of treatment with study medication, symptoms at 2 hours following treatment, time of relief, recurrence of symptoms within 24 hours post-treatment, and adverse events will be dispensed with study medication. Subjects may take a 2nd dose of study medication or medication determined by the investigator for rescue of persistent or recurring headache at 2 or more hours following the 1st dose of study medication. Alternate rescue medication can be provided at the discretion of the investigator but may not include triptan, non-steroidal anti-inflammatory (short-acting NSAID between 6 hours before and 2 hours after study medication or long-acting NSAID between 24 hours before and 24 hours after study medication), or ergotamine-containing or ergot-type medication. Subjects must be headache-free for 24 hours before recording the onset of a "new" migraine attack. The study coordinator will contact subjects at Month 1 to verify treatment and diary compliance.
At Visit 2, following 2 months of treatment with Treximet™, the subject will return to the study site and return completed Headache Diaries. The End of Study CORS, CORS Comparator and End of Study PPMQ-R will be completed considering response with study medication. Adverse events will be documented and Diaries and Questionnaires will be reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treximet | Experimental | Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours. | Drug | Treximet |
Primary outcome
Change in Scores From Completeness of Response Survey (CORS)
Time frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy. The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication).
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16109111Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005 Sep;45(8):983-91. doi: 10.1111/j.1526-4610.2005.05178.x.
- Background: PubMed 17405970Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
- Background: PubMed 10993991Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62. doi: 10.1212/wnl.55.6.754. No abstract available.
- Derived from this study: PubMed 21592098Cady R, Banks J, Nett RB, Goldstein J, Bennett N, Turner IM, Ruoff GE, Landy SH, Farmer K, Juhasz M, Tarrasch J, Runken MC. Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey. Headache. 2011 Jun;51(6):961-70. doi: 10.1111/j.1526-4610.2011.01912.x. Epub 2011 May 17.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger K Cady, MD principal investigator
Clinvest
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) in people with Migraine, run by Cady, Roger, M.D. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores From Completeness of Response Survey (CORS) (time frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.