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| Sponsor: | Cady, Roger, M.D. |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by (Responsible Party): | Cady, Roger, M.D. |
| ClinicalTrials.gov Identifier: | NCT01053507 |
Purpose
This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Headache |
Drug: sumatriptan/naproxen sodium Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction |
| Estimated Enrollment: | 54 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treximet
In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.
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Drug: sumatriptan/naproxen sodium
Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.
Other Name: Treximet
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Placebo Comparator: Placebo
In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
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Drug: Placebo
Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.
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Subjects will be enrolled at 3 investigative sites. At Visit 1, a medical, headache, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An ECG will be completed if one has not been completed in the previous 6 months. Subjects will be administered a series of psychological tests to help the study doctor decide whether or not a subject is eligible. The Headache Impact Test-6 and Migraine Specific Quality of Life Questionnaire will be completed at each visit. During a 30-day Baseline Period, subjects will treat with their usual medication and complete a daily Diary documenting headache symptoms and treatment. At Visits 2 and 3 subjects will complete the Mental Efficiency Workload Test and Migraine Early Warning Tool. Following randomization at Visit 2, subjects will treat daily for 30 days with Treximet or a matching placebo. Subjects will be provided with Treximet for rescue of any persisting or recurring headache. During the Treatment Period, subjects will complete a daily Diary reporting headache symptoms and response to treatment. After the 30-day Treatment Period, subjects will exit the study at Visit 3 .
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject
Exclusion Criteria:
Subject
Contacts and Locations| United States, Missouri | |
| Clinvest | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Debbie Milligan, RN 417-841-3625 dmilligan@clinvest.com | |
| Contact: Rhonda Cadle, RN 417-841-3644 rcadle@clinvest.com | |
| Principal Investigator: Roger K Cady, MD | |
| United States, Tennessee | |
| Nashville Neuroscience Group, PC | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Jonathan R Martin 615-284-4690 jmartin@nashvilleneuroscience.com | |
| Principal Investigator: Jan L Brandes, MD | |
| United States, Texas | |
| Scott & White Memorial Hospital and Clinic | Terminated |
| Temple, Texas, United States, 76508 | |
| Principal Investigator: | Roger K Cady, MD | Clinvest |
More Information
| Responsible Party: | Cady, Roger, M.D. |
| ClinicalTrials.gov Identifier: | NCT01053507 History of Changes |
| Other Study ID Numbers: | 114126 |
| Study First Received: | January 19, 2010 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Headache Post-traumatic headache Brain injury Cognitive impairment |
|
Headache Post-Traumatic Headache Cognition Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Naproxen Sumatriptan |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |