A Phase 4 interventional study of Sumatriptan/Naproxen Sodium and Naproxen Sodium in Chronic Migraine, sponsored by Cady, Roger, M.D.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-03.
Sponsored by Cady, Roger, M.D. · Phase 4, Interventional, and Treatment
This study is being conducted to evaluate the hypothesis that use of Treximet in patients with chronic migraine, when used on a short term daily basis and as rescue for break through attacks, will reduce migraine frequency and impact.
One investigative center will enroll 40 subjects in the US.
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. A 12-lead ECG will be completed. Eligible subjects will complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice. Throughout the study, subjects will complete daily Headache Diaries reporting headache severity and associated symptoms with use of study medication in each 30-day period.
At Visit 2, subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with medication to treat daily for 30 days. At Visits 3 and 4 subjects will be 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. Adverse events will be collected beginning from the first dose of study medication. Subjects exit the study at Visit 5 after a 3-month Treatment Period.
The study provides opportunity to evaluate the usefulness of patient education with a 15-minute digital versatile disc (DVD) concerning the processes of headache evolution and lifestyle changes for better headache management. At Visit 2, subjects will view the DVD in-clinic with a copy provided for at-home viewing. Subjects will complete a Lifestyle Choices for Better Migraine Management Questionnaire at each visit and receive 3 copies to be completed weekly and returned at the following visit.
The Migraine Disability Assessment questionnaire (MIDAS) will be completed at Visits 2 and 5 to determine the level of pain and disability caused by headache.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Cady, Roger, M.D. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Subject
Exclusion Criteria:
Subject
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan 85mg / Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
Drug: Sumatriptan/Naproxen Sodium
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Drug: Naproxen Sodium
Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
Also known as: Treximet
Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
Percent Change of Migraine Headache Days Compared to Baseline
Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (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%)
Time frame: Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.
Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. 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%)
Time frame: Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.
Migraine Headache Duration From Onset to Pain Free
Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the 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 each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=\[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)\]\*100%)
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.
Migraine Headache Duration From Time of Treatment to Pain Free
Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the 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 each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=\[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)\]\*100%)
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.
Migraine Headache Days With Greater Than 50% Reduction
Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.
Percent Change of Doses of Study Medication
Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.Percent change=\[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)\]\*100%).
Time frame: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.
Migraine Disability Assessment(MIDAS)Questionnaire Total Score
Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the 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 Score ranges from 0-450. No subscales are present.
Time frame: Baseline MIDAS collected at Day 31, Post final dose study 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) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.
Time frame: Day 121
Recruitment period was from date of Institutional Review Board (IRB) approval (8-3-10) until date last patient enrolled (1-30-12). Subjects were recruited from general population at two clinical research centers.
| Milestone | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Started | 16 | 12 |
| Completed | 15 | 5 |
| Not completed | 1 | 7 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 5 |
| Withdrew: Physician decision | 0 | 1 |
Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (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%)
| percent migraine headache days per month | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Percent Change of Migraine Headache Days Compared to Baseline | -8.06 ± 32.9 | -56.37 ± 36.2 |
Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. 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%)
| percent migraine headache days per month | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Baseline to Treatment Period Month 1 | -26.22 ± 31.4 | -61.55 ± 23.9 |
| Baseline to Treatment Period Month 2 | -2.96 ± 23.7 | -45.42 ± 36.0 |
| Baseline to Treatment Period Month 3 | -8.06 ± 32.9 | -56.37 ± 36.2 |
Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the 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 each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=\[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)\]\*100%)
| percent hours of migraine duration | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Baseline to Treatment Period Month 1 | 167.83 ± 230.48 | 26.37 ± 13.11 |
| Baseline to Treatment Period Month 2 | 176.18 ± 227.97 | 28.91 ± 21.21 |
| Baseline to Treatment Period Month 3 | 151.49 ± 224.53 | 19.65 ± 30.82 |
Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the 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 each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation. e.g. Percent change=\[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)\]\*100%)
| percent hours of migraine duration | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Baseline to Treatment Period Month 1 | 176.70 ± 233.18 | 24.58 ± 12.21 |
| Baseline to Treatment Period Month 2 | 175.78 ± 228.08 | 28.45 ± 21.03 |
| Baseline to Treatment Period Month 3 | 151.12 ± 224.45 | 23.15 ± 38.78 |
Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
| participants | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Baseline to Treatment Period Month 1 | 3 | 4 |
| Baseline to Treatment Period Month 2 | 0 | 3 |
| Baseline to Treatment Period Month 3 | 3 | 4 |
Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.Percent change=\[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)\]\*100%).
| percent doses of study medication | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Baseline to Treatment Period Month 1 | 173.8 ± 194 | 825.6 ± 1649.9 |
| Baseline to Treatment Period Month 2 | 40.1 ± 84 | 239.8 ± 575.8 |
| Baseline to Treatment Period Month 3 | 40.0 ± 147 | 135.6 ± 379.33 |
Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the 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 Score ranges from 0-450. No subscales are present.
| scores on a scale | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Day 31 | 76.6 ± 38.6 | 81.2 ± 52.9 |
| Day 121 | 56.3 ± 44.5 | 16.4 ± 9.2 |
Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.
| Units on a scale | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Compliance With Lifestyle Changes | 2.00 ± 0.65 | 2.40 ± 0.55 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sumatriptan/Naproxen Sodium | — | 1/16 (6.3%) | 9/16 (56.3%) |
| Naproxen Sodium | — | 1/12 (8.3%) | 6/12 (50%) |
| Event | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| CholecystitisGastrointestinal disorders | 0/16 | 1/12 |
| MenorragiaReproductive system and breast disorders | 1/16 | 0/12 |
| Event | Sumatriptan/Naproxen Sodium | Naproxen Sodium |
|---|---|---|
| Common ColdRespiratory, thoracic and mediastinal disorders | 2/16 | 1/12 |
| Abdominal PainGastrointestinal disorders | 0/16 | 1/12 |
| CholecystitisGastrointestinal disorders | 0/16 | 1/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/16 | 1/12 |
| DizzinessGeneral disorders | 1/16 | 1/12 |
| Enhanced SmellGeneral disorders | 0/16 | 1/12 |
| FeverInfections and infestations | 1/16 | 1/12 |
| FluInfections and infestations | 1/16 | 1/12 |
| Fluid in EarsEar and labyrinth disorders | 0/16 | 1/12 |
| Muscle painMusculoskeletal and connective tissue disorders | 1/16 | 1/12 |
| Age, Categorical(Participants) | Sumatriptan/Naproxen Sodium | Naproxen Sodium | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 12 | 28 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Sumatriptan/Naproxen Sodium | Naproxen Sodium | Total |
|---|---|---|---|
| Mean | 43.8 ± 12.6 | 37.0 ± 8.6 | 40.9 ± 11.4 |
| Sex: Female, Male(Participants) | Sumatriptan/Naproxen Sodium | Naproxen Sodium | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 4 | 2 | 6 |
| Region of Enrollment(participants) | Sumatriptan/Naproxen Sodium | Naproxen Sodium | Total |
|---|---|---|---|
| United States | 16 | 12 | 28 |
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Cady, Roger, M.D.