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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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 Treximetâ„¢ 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 (Treximetâ„¢).
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 Treximetâ„¢ 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 Treximetâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subject must be/have
Exclusion Criteria:
Subject has/is
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| Name | Affiliation | Role |
|---|---|---|
| Roger K Cady, MD | Clinvest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States | ||
| Westside Family Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16109111 | Background | 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. | |
| 17405970 | Background | Brandes 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. |
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First Patient In 6/2/09 Last Patient In 7/17/09 Patients enrolled at 5 Headache Specialty clinics, 2 Primary Care practices, and 1 Neurological practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Number | Percent of Participants | Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Verbatim Response | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Tightness | General disorders | Verbatim Response | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Browning | Clinvest | (417) 841-3664 | rbrowning@clinvest.com |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| C000611385 | sumatriptan-naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| 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. | Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) |
| Kalamazoo |
| Michigan |
| 49009 |
| United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Mercy Health Research/Ryan Headache Center | St Louis | Missouri | 63141 | United States |
| Island Neurological Associates, PC | Plainview | New York | 11803 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | United States |
| Wesley Headache Clinic and Research Center | Cordova | Tennessee | 38018 | United States |
| Texas Headache Associates | San Antonio | Texas | 78258 | United States |
| 10993991 | Background | Silberstein 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. |
| 21592098 | Derived | Cady 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) |
|
|
|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | Units on a scale | Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) |
|
|
|
| 2 |
| 147 |
| 28 |
| 147 |
| Migraine without aura | Nervous system disorders | Verbatim Response | Systematic Assessment | without intractable headache, but with Status Migrainosus |
|
| Dizziness | Nervous system disorders | Verbatim Response | Systematic Assessment |
|
| Jittery | General disorders | Verbatim Response | Systematic Assessment |
|
| Light Headed | Nervous system disorders | Verbatim Response | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Verbatim Response | Systematic Assessment |
|
| Sleepy | Nervous system disorders | Verbatim Response | Systematic Assessment |
|
| Tired | Nervous system disorders | Verbatim Response | Systematic Assessment |
|
Publication of Results is specifically authorized, subject to the provisions of STUDY AGREEMENT. INVESTIGATOR is free to publish Results of its part of study in collaboration with other investigators, but in compliance with confidentiality agreement and subsequent to full study publication issued by CLINVEST. INVESTIGATOR agrees to submit a copy of any results communication to CLINVEST for review and comment 60 days prior to submission for publication.
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Cost |
|
| Title | Measurements |
|---|---|
|
| Functionality Score |
|