MigrainePhase 4NCT01300546
Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
A Phase 4 study testing Sumatriptan/Naproxen Sodium and Naproxen Sodium in people with Migraine, run by Cady, Roger, M.D. at 2 sites in United States.
Trial summary
This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Sumatriptan/Naproxen Sodium and Naproxen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Apr 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject
- Is male or female, in otherwise good health, 18 to 65 years of age.
- Has history of frequent episodic migraine (6-14 migraine days per month) (with or without aura) according to the 2nd Edition of The International Headache Classification (ICHD-2) for at least 3 months. (Stage 2-3 frequent transforming migraine)
- Had onset of migraine before age 50.
- Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
- Has stable history of headache at least 3 months prior to screening.
Show all 16Show fewer
- Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
- Has at least 50% of migraine attacks beginning at mild severity.
- If female of childbearing potential, has a negative urine pregnancy test at Visits 1-5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator.
- Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or,
- Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
- Sterilization of male partner; or,
- Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
- Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
- Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
- Had 6 or more migraine treatment days in 1 month prior to Visit 2.
Who cannot join
- Subject
- Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
- Is pregnant, actively trying to become pregnant, or breast-feeding.
- Has experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine.
- Has a history of Medication Overuse Headache in the 3 months prior to study enrollment or during the baseline phase
- Has history of acute migraine treatment greater than14 days per month in 3 months prior to screening.
Show all 30Show fewer
- Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year:
- opioids
- alcohol
- barbiturates
- benzodiazepine
- cocaine
- Has history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
- Has an unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
- Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome; has uncontrolled hypertension (≥140/90 millimeters of mercury (mmHg) in 2 out of 3 blood pressure (BP) measurements at screening); has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator.
- Has a history of asthma and nasal polyps.
- Has a history of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment
- Has evidence or history of any gastrointestinal (GI) surgery or GI ulceration or perforation of the stomach or intestine in the past 6 months, gastrointestinal bleeding in the past year or evidence or history of inflammatory bowel disease or history of any other bleeding disorder, or has taken or plans to take any anti-coagulant or any antiplatelet agent within the 2 weeks prior to screening through 48 hours post final study treatment.
- Has history of non-steroidal anti-inflammatory drug induced gastritis, esophagitis, or duodenitis.
- Suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.
- Has in the opinion of the investigator a significant cardiovascular risk profile that may include uncontrolled high blood pressure, post-menopausal women, male over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative.
- Has in the opinion of the investigator a significant cerebrovascular risk profile that may include female over the age of 35 using oral birth control, smoking, or a family history of cerebrovascular disease in a first degree relative.
- Has a psychiatric condition, in the opinion of the investigator that may affect the interpretation of efficacy and safety data or contraindicates the subject's participation in the study.
- Has hypersensitivity, intolerance, or contraindication to the use of sumatriptan, any of its components, or any other 5-hydroxytryptamine 1 (5-HT1) agonist.
- Has a hypersensitivity, intolerance, or contraindication to the use of naproxen, any of its components, or any other non-steroidal anti-inflammatory drug including aspirin and cyclooxygenase-2 (COX-2) inhibiting agents.
- Is currently taking a migraine prophylactic medication containing an ergotamine or ergot derivative such as dihydroergotamine (DHE) or methysergide.
- Has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. John's wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
- Has taken or plans to take an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) anytime within the 2 weeks prior to screening through 48 hours post final study treatment.
- Has received any investigational agents within 30 days prior to Visit 1.
- Plans to participate in another clinical study at any time during this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Newport Beach Clinical Research Assoc., Inc.
Newport Beach, California, 92663
Clinvest
Springfield, Missouri, 65807
About this study
Official title: TreximetTM in the Prevention and Modification of Disease Progression in Migraine
This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.
Read the detailed description
Two investigative centers will enroll 40 subjects in the United States. Subject participation in the 5 visit study will last 4 months.
At Visit 1, following informed consent, a medical, migraine, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An electrocardiogram (ECG) will be completed. A Lifestyle Choices for Better Migraine Management Questionnaire (Lifestyle Questionnaire) will be completed. Eligible subjects then complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice, documenting headache severity and associated symptoms in a 30-day Baseline Diary.
At Visit 2, the Baseline Diary will be reviewed and a pregnancy test will be collected from all subjects of childbearing potential. Vital signs will be collected and Adverse Events documented. Subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with study medication to treat on 14 or fewer days per month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of headache pain and while the pain is still mild. Subjects will view an educational digital video disc (DVD) concerning lifestyle modification, receive a copy for home viewing, complete the Lifestyle Questionnaire, and receive 3 copies of the Lifestyle Questionnaire for weekly completion between Visits 2 and 3. The Migraine Disability Assessment questionnaire (MIDAS) will be completed and a 30-day Treatment Period Diary will be dispensed.
At Visits 3 and 4, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected, a Lifestyle Questionnaire will be completed in the office, and 3 copies will be dispensed for weekly completion between visits. Study medication for the following month will be dispensed with a 30-day Diary.
At Visit 5, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected and a Lifestyle Questionnaire will be completed in the office. Subjects will complete the MIDAS before exiting the study.
- Conditions
- Migraine
- Being tested
- Sumatriptan/Naproxen Sodium, Naproxen Sodium
- Keywords
- Frequent migraine, Migraine transformation, Migraine, Treximet, Naproxen, Sumatriptan
- 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/Naproxen SodiumDrug
Also called Treximet
Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.
Naproxen SodiumDrug
Also called Naproxen
Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan/Naproxen Sodium | Active comparator | In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache. Receives: Drug: Sumatriptan/Naproxen Sodium |
| Naproxen Sodium | Active comparator | In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache. Receives: Drug: Naproxen Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Headache Days Compared to Baseline
Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).
Measured: Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)
Secondary outcomes (11)
Migraine Attacks
Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Severity
Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Duration From Onset to Pain Free
Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Duration From Time of Treatment to Pain Free
% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%).
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Headache Days With Greater Than 50% Reduction
Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Attacks With 50% Reduction
Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Doses of Study Medication
Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Measured: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Percent Change of Doses of Study Medication
% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.
Measured: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Disability Assessment Test (MIDAS)
Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Total score of disability ranges:
- 0 to 5, MIDAS Grade I, Little or no disability
- 6 to 10, MIDAS Grade II, Mild disability
- 11 to 20, MIDAS Grade III, Moderate disability
- 21+, MIDAS Grade IV, Severe disability No subscales are present.
Measured: Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.
Compliance With Lifestyle Changes
Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Measured: Day 121
Percent Change in Headache Days All Treatment Periods Compared to Baseline
Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).
Measured: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionApr 2012
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 (9)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Roger K Cady, MD, Principal investigator, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300546
- Sponsor's protocol ID
- 114933
- Status last verified
- May 2013
- First submitted
- 12 Jan 2011
- Last updated
- 21 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cady RK, Goldstein J, Silberstein S, Juhasz M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. doi: 10.1111/j.1526-4610.2009.01532.x. Epub 2009 Oct 8.
PubMed 19817885Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
PubMed 19472447Bigal ME, Sheftell FD, Rapoport AM, Lipton RB, Tepper SJ. Chronic daily headache in a tertiary care population: correlation between the International Headache Society diagnostic criteria and proposed revisions of criteria for chronic daily headache. Cephalalgia. 2002 Jul;22(6):432-8. doi: 10.1046/j.1468-2982.2002.00384.x.
PubMed 12133042Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.
PubMed 16686915Lipton RB, Stewart WF, Cady R, Hall C, O'Quinn S, Kuhn T, Gutterman D. 2000 Wolfe Award. Sumatriptan for the range of headaches in migraine sufferers: results of the Spectrum Study. Headache. 2000 Nov-Dec;40(10):783-91. doi: 10.1046/j.1526-4610.2000.00143.x.
PubMed 11135021Newman LC, Lipton RB, Lay CL, Solomon S. A pilot study of oral sumatriptan as intermittent prophylaxis of menstruation-related migraine. Neurology. 1998 Jul;51(1):307-9. doi: 10.1212/wnl.51.1.307.
PubMed 9674831Foley KA, Cady R, Martin V, Adelman J, Diamond M, Bell CF, Dayno JM, Hu XH. Treating early versus treating mild: timing of migraine prescription medications among patients with diagnosed migraine. Headache. 2005 May;45(5):538-45. doi: 10.1111/j.1526-4610.2005.05107.x.
PubMed 15953272Rapoport AM, Bigal ME, Volcy M, Sheftell FD, Feleppa M, Tepper SJ. Naratriptan in the preventive treatment of refractory chronic migraine: a review of 27 cases. Headache. 2003 May;43(5):482-9. doi: 10.1046/j.1526-4610.2003.03094.x.
PubMed 12752754Sheftell FD, Rapoport AM, Tepper SJ, Bigal ME. Naratriptan in the preventive treatment of refractory transformed migraine: a prospective pilot study. Headache. 2005 Nov-Dec;45(10):1400-6. doi: 10.1111/j.1526-4610.2005.00273.x.
PubMed 16324173
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TreximetTM in the Prevention and Modification of Disease Progression in Migraine
- ClinicalTrials.gov ID
- NCT01300546
- Acronym / sponsor ID
- 114933
- Conditions
- Migraine
- Keywords
- Frequent migraine, Migraine transformation, Migraine, Treximet, Naproxen, Sumatriptan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Posted 21 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.
Detailed description
Two investigative centers will enroll 40 subjects in the United States. Subject participation in the 5 visit study will last 4 months.
At Visit 1, following informed consent, a medical, migraine, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An electrocardiogram (ECG) will be completed. A Lifestyle Choices for Better Migraine Management Questionnaire (Lifestyle Questionnaire) will be completed. Eligible subjects then complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice, documenting headache severity and associated symptoms in a 30-day Baseline Diary.
At Visit 2, the Baseline Diary will be reviewed and a pregnancy test will be collected from all subjects of childbearing potential. Vital signs will be collected and Adverse Events documented. Subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with study medication to treat on 14 or fewer days per month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of headache pain and while the pain is still mild. Subjects will view an educational digital video disc (DVD) concerning lifestyle modification, receive a copy for home viewing, complete the Lifestyle Questionnaire, and receive 3 copies of the Lifestyle Questionnaire for weekly completion between Visits 2 and 3. The Migraine Disability Assessment questionnaire (MIDAS) will be completed and a 30-day Treatment Period Diary will be dispensed.
At Visits 3 and 4, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected, a Lifestyle Questionnaire will be completed in the office, and 3 copies will be dispensed for weekly completion between visits. Study medication for the following month will be dispensed with a 30-day Diary.
At Visit 5, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected and a Lifestyle Questionnaire will be completed in the office. Subjects will complete the MIDAS before exiting the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan/Naproxen Sodium | Active comparator | Drug: Sumatriptan/Naproxen SodiumIn Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache. |
| Naproxen Sodium | Active comparator | Drug: Naproxen SodiumIn Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject
- Is male or female, in otherwise good health, 18 to 65 years of age.
- Has history of frequent episodic migraine (6-14 migraine days per month) (with or without aura) according to the 2nd Edition of The International Headache Classification (ICHD-2) for at least 3 months. (Stage 2-3 frequent transforming migraine)
- Had onset of migraine before age 50.
- Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
Key exclusion criteria (30 listed)
- Subject
- Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
- Is pregnant, actively trying to become pregnant, or breast-feeding.
- Has experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine.
- Has a history of Medication Overuse Headache in the 3 months prior to study enrollment or during the baseline phase
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/Naproxen SodiumAlso: TreximetEach tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period. | Drug | Sumatriptan/Naproxen Sodium |
| Naproxen SodiumAlso: NaproxenEach tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period. | Drug | Naproxen Sodium |
Primary outcome
Percent Change of Headache Days Compared to Baseline
Time frame: Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)
Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).
11 secondary outcomes
Migraine Attacks
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Severity
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Duration From Onset to Pain Free
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Duration From Time of Treatment to Pain Free
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Headache Days With Greater Than 50% Reduction
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Attacks With 50% Reduction
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Doses of Study Medication
Time frame: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Percent Change of Doses of Study Medication
Time frame: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Migraine Disability Assessment Test (MIDAS)
Time frame: Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.
Compliance With Lifestyle Changes
Time frame: Day 121
Percent Change in Headache Days All Treatment Periods Compared to Baseline
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19817885Cady RK, Goldstein J, Silberstein S, Juhasz M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. doi: 10.1111/j.1526-4610.2009.01532.x. Epub 2009 Oct 8.
- Background: PubMed 19472447Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
- Background: PubMed 12133042Bigal ME, Sheftell FD, Rapoport AM, Lipton RB, Tepper SJ. Chronic daily headache in a tertiary care population: correlation between the International Headache Society diagnostic criteria and proposed revisions of criteria for chronic daily headache. Cephalalgia. 2002 Jul;22(6):432-8. doi: 10.1046/j.1468-2982.2002.00384.x.
- Background: PubMed 16686915Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.
- Background: PubMed 11135021Lipton RB, Stewart WF, Cady R, Hall C, O'Quinn S, Kuhn T, Gutterman D. 2000 Wolfe Award. Sumatriptan for the range of headaches in migraine sufferers: results of the Spectrum Study. Headache. 2000 Nov-Dec;40(10):783-91. doi: 10.1046/j.1526-4610.2000.00143.x.
- Background: PubMed 9674831Newman LC, Lipton RB, Lay CL, Solomon S. A pilot study of oral sumatriptan as intermittent prophylaxis of menstruation-related migraine. Neurology. 1998 Jul;51(1):307-9. doi: 10.1212/wnl.51.1.307.
- Background: PubMed 15953272Foley KA, Cady R, Martin V, Adelman J, Diamond M, Bell CF, Dayno JM, Hu XH. Treating early versus treating mild: timing of migraine prescription medications among patients with diagnosed migraine. Headache. 2005 May;45(5):538-45. doi: 10.1111/j.1526-4610.2005.05107.x.
- Background: PubMed 12752754Rapoport AM, Bigal ME, Volcy M, Sheftell FD, Feleppa M, Tepper SJ. Naratriptan in the preventive treatment of refractory chronic migraine: a review of 27 cases. Headache. 2003 May;43(5):482-9. doi: 10.1046/j.1526-4610.2003.03094.x.
- Background: PubMed 16324173Sheftell FD, Rapoport AM, Tepper SJ, Bigal ME. Naratriptan in the preventive treatment of refractory transformed migraine: a prospective pilot study. Headache. 2005 Nov-Dec;45(10):1400-6. doi: 10.1111/j.1526-4610.2005.00273.x.
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
2 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/Naproxen Sodium and Naproxen Sodium in people with Migraine, run by Cady, Roger, M.D. at 2 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 16 inclusion and 30 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 21 May 2013). 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?
Percent Change of Headache Days Compared to Baseline (time frame: Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)). 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 NCT01300546, which also lists 9 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 21 May 2013.