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Sponsors and Collaborators: |
Cady, Roger, M.D. GlaxoSmithKline Clinvest |
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Information provided by: | Cady, Roger, M.D. |
ClinicalTrials.gov Identifier: | NCT00487578 |
The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.
Condition | Intervention | Phase |
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Post Traumatic Headache |
Drug: naratriptan HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of the Efficacy of Naratriptan for the Treatment and Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction |
Estimated Enrollment: | 56 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Naratriptan 2.5 mg tablet bid x 30 days
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Drug: naratriptan HCl
naratriptan 2.5mg tablet bid x 30 days OR matching placebo
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B: Placebo Comparator
placebo matching naratriptan 2.5 mg tablet
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Drug: naratriptan HCl
naratriptan 2.5mg tablet bid x 30 days OR matching placebo
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Naratriptan has demonstrated efficacy in relieving headache. Other studies have demonstrated that primary headaches with at least one headache feature are likely to respond to triptans. In addition, there are anecdotal reports of triptans being effective in post traumatic headaches, especially if headache features are noted in the patient's history. Further, there are several small pilot studies with triptans demonstrating a prompt improvement in headache-induced cognitive changes. Cognitive performance can be measured by the Mental Efficiency Workload Test (MEWT), a handheld Palm neuropsychological test battery that measures mental efficiency. This tool can be used to demonstrate short and long term improvement in mental status beyond that seen at baseline.
Informal observations by the protocol authors have suggested that the use of triptans on a routine basis may ameliorate the headache and associated symptomatology of post traumatic headache. Therefore, this study is undertaken to study the use of naratriptan in the treatment of post traumatic headache. Roger K. Cady, MD, serves as the sponsor. The study is funded by GlaxoSmithKline.
56 subjects with a formal diagnosis of Chronic post-traumatic headache attributed to mild head injury (IHS/ICHD-II 5.2.2) and with self-reported mild cognitive inefficiency secondary to headache will be enrolled at two sites in the U.S. (Headache Care Center/Clinvest, Springfield, MO and National Rehabilitation Hospital, Washington, D.C.). Subjects meeting inclusion criteria will complete a physical examination and baseline testing and be randomized 1:1 to naratriptan 2.5mg bid x 30 days or a matched placebo bid x 30 days. A daily diary will document response to treatment. Subjects will return to the clinic at Day 10 and Day 30 and complete phone contacts at Days 5, 15, 21, 32 and 90. Information will be collected throughout the study on questionnaires related to headache impact, general health, satisfaction with medication, and quality of life. Cognition will be measured using the MEWT.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Clinvest | Recruiting |
Springfield, Missouri, United States, 65807 | |
Contact: Rhonda Cadle, RN 417-841-3644 rcadle@clinvest.com | |
Contact: Debbie Milligan, RN 417-841-3625 dmilligan@clinvest.com | |
Principal Investigator: Roger K Cady, MD | |
Sub-Investigator: Dennis L Reeves, PhD | |
Sub-Investigator: Kathleen U Farmer, PsyD | |
Sub-Investigator: John K Dexter, MD | |
Sub-Investigator: Curtis P Schreiber, MD | |
United States, North Carolina | |
Carolinas Rehabilitation, Carolinas HealthCare System | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Marybeth Whitney, BSN 704-355-1409 Marybeth.Whitney@carolinashealthcare.org | |
Principal Investigator: Flora Hammond, MD | |
Sub-Investigator: Lori M Grafton, MD | |
Sub-Investigator: Andrew Dennison, MD | |
Sub-Investigator: Shilpa Kasuganti, MD | |
United States, Texas | |
Anodyne Headache and Pain Care | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Virginia Krusz 214-750-6664 nodynia@swbell.net | |
Principal Investigator: John C Krusz, MD |
Principal Investigator: | Roger K Cady, MD | Clinvest |
Responsible Party: | Clinvest ( Cady, Roger, M.D./CEO ) |
Study ID Numbers: | 106542 |
Study First Received: | June 14, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00487578 |
Health Authority: | United States: Food and Drug Administration |
Post traumatic headache Head trauma Head injury Headache Naratriptan |
Craniocerebral Trauma Wounds and Injuries Post-Traumatic Headache Central Nervous System Diseases Pain Brain Diseases Naratriptan Serotonin Cognition Disorders Headache Disorders |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Headache Disorders, Secondary Mental Disorders Headache Neoplasm Metastasis Neurologic Manifestations Dementia Delirium |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |