- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00792636
A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
October 11, 2016 updated by: GlaxoSmithKline
Assessment of the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet Treatment on Blood Pressure When Administered Intermittently for Six Months for the Acute Treatment of Migraine Attacks, With or Without Aura, in Adults
The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
407
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Chandler, Arizona, United States, 85224
- GSK Investigational Site
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Gilbert, Arizona, United States, 85234
- GSK Investigational Site
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Litchfield Park, Arizona, United States, 85340
- GSK Investigational Site
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Phoenix, Arizona, United States, 85050
- GSK Investigational Site
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Tempe, Arizona, United States, 85283
- GSK Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- GSK Investigational Site
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California
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Anaheim, California, United States, 92801
- GSK Investigational Site
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Anaheim, California, United States, 92805
- GSK Investigational Site
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Buena Park, California, United States, 90620
- GSK Investigational Site
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Garden Grove, California, United States, 92845
- GSK Investigational Site
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Newport Beach, California, United States, 92660
- GSK Investigational Site
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Santa Monica, California, United States, 90404
- GSK Investigational Site
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Westlake Village, California, United States, 91361
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80904
- GSK Investigational Site
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Connecticut
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Avon, Connecticut, United States, 06001
- GSK Investigational Site
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Florida
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Hialeah, Florida, United States, 33010
- GSK Investigational Site
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Jacksonville, Florida, United States, 32216
- GSK Investigational Site
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Miami, Florida, United States, 33143
- GSK Investigational Site
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Pembroke Pines, Florida, United States, 33024
- GSK Investigational Site
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St. Petersburg, Florida, United States, 33702
- GSK Investigational Site
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Sunrise, Florida, United States, 33351
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30308
- GSK Investigational Site
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Decatur, Georgia, United States, 30034
- GSK Investigational Site
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Illinois
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Chicago, Illinois, United States, 60614
- GSK Investigational Site
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Kansas
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Wichita, Kansas, United States, 67207
- GSK Investigational Site
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Michigan
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Kalamazoo, Michigan, United States, 49009
- GSK Investigational Site
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Missouri
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Springfield, Missouri, United States, 65807
- GSK Investigational Site
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St. Louis, Missouri, United States, 63141
- GSK Investigational Site
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North Carolina
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Greensboro, North Carolina, United States, 27405
- GSK Investigational Site
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Harrisburg, North Carolina, United States, 28075
- GSK Investigational Site
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Matthews, North Carolina, United States, 28105
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27612
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27609
- GSK Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44122
- GSK Investigational Site
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West Chester, Ohio, United States, 45069
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- GSK Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15236
- GSK Investigational Site
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- GSK Investigational Site
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Simpsonville, South Carolina, United States, 29681
- GSK Investigational Site
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Tennessee
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Bristol, Tennessee, United States, 37620
- GSK Investigational Site
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Memphis, Tennessee, United States, 38018
- GSK Investigational Site
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Nashville, Tennessee, United States, 37203
- GSK Investigational Site
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Texas
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Austin, Texas, United States, 78705
- GSK Investigational Site
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Houston, Texas, United States, 77004
- GSK Investigational Site
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San Antonio, Texas, United States, 78205
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84107
- GSK Investigational Site
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West Jordan, Utah, United States, 84088
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
Male and female outpatients 18 to 65 years of age. Female subjects are eligible for participation in the study if they are:
- Females of non-childbearing potential
- Females of childbearing potential and who have a negative urine pregnancy test at Screening and agree to use one of the GlaxoSmithKline specified highly effective methods for avoiding pregnancy. Subjects taking oral contraceptives must be on a stable regimen for at least two months prior to Screening.
- Subject with migraines, with or without aura (ICHD-II criteria, 1.2.1 or 1.1) [International Headache Society, 2004]. Subject must have a history of two to eight attacks per month, on average, for the six months prior to the Screening Visit. Additionally the subject is to have experienced at least two, but no more than eight, migraine attacks per month for the three months prior to Screening Visit.
- Subject is able to distinguish migraine attacks from other headaches (i.e. tension-type headaches).
- Subject is willing and able to provide written informed consent, to comprehend and perform the requirements of the protocol.
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
- Subject has ≥10 migraine attacks or ≥15 headache days per month in total (including migraine, probable migraine or tension-type headache).
- Subject has retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches [International Headache Society, 2004].
- Subject has a history of controlled or uncontrolled hypertension or is currently taking any angiotension-converting enzyme (ACE) inhibitor or angiotension receptor blocker.
- Subject has an in-clinic screening blood pressure of ≥ 130/85 mmHg in two out of three blood pressure measurements.
- Subject is taking any anti-hypertensive medication for any reason including for migraine prophylaxis.
- Subject has a glycosylated hemoglobin ≥ 8.0
- Subject has a chronic condition (i.e. osteoarthritis, rheumatoid arthritis,fibromyalgia) which requires chronic daily administration of non-steroidal anti-inflammatory drugs (NSAIDS) (including acetaminophen) or opioids or opioid combination products.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
- Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in the study.
- Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or any signs or symptoms consistent with any of the above.
- Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within five years prior to Screening.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in the study.
- Subject has hypersensitivity, allergy, intolerance or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
- Subject is currently taking, or has used, an ergot or ergot-derived medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e. change of a dose within the past two months) for chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
- Subject has a recent history of regular use of opioids or barbiturates for the treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of four days per month over the last six months.
- Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum) or a CNS stimulant medication (such as atomoxetine, dextroamphetamine and amephetamine products, dexmethlyphenidate, lisdexamdetamine dimesylate and methylphenidate) anytime within two weeks prior to Screening through two-weeks post-treatment.
- Subject has a history of any bleeding disorder or is currently taking any anticoagulant or any anti-platelet agent. (except low-dose aspirin <=325mg/day for cardioprotective reasons).
- Subject has evidence or history of any gastrointestinal surgery, gastrointestinal ulceration or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.
- Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy tests performed as required.
- Subject tests positive for illicit substances on toxicology screen or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
- Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: sumatriptan and naproxen sodium combination
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sumatriptan 85mg and naproxen sodium 500mg
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ACTIVE_COMPARATOR: sumatriptan
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sumatriptan 85mg
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ACTIVE_COMPARATOR: naproxen sodium
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Naproxen sodium 500mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Time Frame: Baseline and Month 6
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The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements.
T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server.
Change from baseline was calculated as the Month 6 value minus the Baseline value.
Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
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Baseline and Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements.
T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server.
Change from baseline was calculated as the Month 6 value minus the Baseline value.
Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
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Baseline and Month 6
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Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements.
T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server.
Change from baseline was calculated as the Month 6 value minus the Baseline value.
Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
|
Baseline and Month 6
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Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements.
T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server.
Change from baseline was calculated as the Month 6 value minus the Baseline value.
Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).
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Baseline and Month 6
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
Time Frame: Baseline and Month 6
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The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements.
The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6.
LSMeans and corresponding confidence intervals were based on MMRM analysis.
LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.
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Baseline and Month 6
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements.
The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6.
LSMeans and corresponding confidence intervals were based on MMRM analysis.
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Baseline and Month 6
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements.
The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.
Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6.
LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis.
LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.
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Baseline and Month 6
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
Time Frame: Baseline and Month 6
|
The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements.
The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.
Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6.
LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis.
LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.
|
Baseline and Month 6
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Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
Time Frame: Baseline to End of Study (6-month study duration)
|
The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized.
Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
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Baseline to End of Study (6-month study duration)
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Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
Time Frame: Baseline to End of Study (6-month study duration)
|
The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized.
Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
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Baseline to End of Study (6-month study duration)
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Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study
Time Frame: Baseline to End of Study (6-month study duration)
|
The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated.
Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
|
Baseline to End of Study (6-month study duration)
|
Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg
Time Frame: Baseline to End of Study (6-month study duration)
|
The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated.
Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
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Baseline to End of Study (6-month study duration)
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Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure
Time Frame: Baseline to End of Study (6-month study duration)
|
Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group.
Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
|
Baseline to End of Study (6-month study duration)
|
Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure
Time Frame: Baseline to End of Study (6-month study duration)
|
Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group.
Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.
|
Baseline to End of Study (6-month study duration)
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Number of Participants Withdrawn From the Study Due to Blood Pressure Changes
Time Frame: Baseline to End of Study (6-month study duration)
|
The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group.
Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.
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Baseline to End of Study (6-month study duration)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
November 1, 2009
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
November 17, 2008
First Submitted That Met QC Criteria
November 17, 2008
First Posted (ESTIMATE)
November 18, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 23, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Gout Suppressants
- Vasoconstrictor Agents
- Naproxen
- Sumatriptan
Other Study ID Numbers
- 110948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Statistical Analysis Plan
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 110948Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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