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Sponsors and Collaborators: |
Clinvest Ortho-McNeil Neurologics, Inc. |
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Information provided by: | Clinvest |
ClinicalTrials.gov Identifier: | NCT00208065 |
The primary objective of this study is to evaluate histamine, CGRP and VIP levels in saliva as biological markers for activation of trigeminal and parasympathetic nerve fibers in various clinical presentations of primary headaches compared to allergic rhinosinusitis and control populations.
Condition | Intervention | Phase |
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Migraine Sinusitis |
Drug: almotriptan or pseudoephedrine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Evaluation of Histamine, CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to "Sinus" Symptoms |
Estimated Enrollment: | 50 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2006 |
It has been suggested that many people with self-diagnosed or physician diagnosed "sinus" headache experience symptoms that fulfill diagnostic criteria for migraine or migrainous headache. The shared symptomatology does not differentiate these disorders."Sinus" symptoms as an early manifestation of migraine may be associated with elevated levels of CGRP suggesting peripheral trigeminal activation whereas "sinus" symptoms late in migraine may have associated elevations of VIP suggesting parasymptathetic activation. Subjects without autonomic or "sinus" symptoms will not have changes in salivatory histamine, CGRP or VIP and will have values similar to controls. Subjects with rhinosinusitis will have levels or patterns of salivatory histamine, CGRP and VIP unique from migraine subjects. If "sinus symptoms" are associated with parasympathetic activation, then there should be detectable increases in VIP early in the course of nasal symptom development and, conversely, if these symptoms associate with trigeminal activation, then increases in CGRP should be detected. Five groups of 10 subjects each will be recruited. Group A without migraine, with self-described "sinus" headache or symptoms of rhinosinusitis. Group B with chronic rhinosinusitis and no history of migraine or "sinus" headache. Group C with "sinus" headache with symptoms meeting IHS criteria for migraine and symptoms of rhinosinusitis preceding the onset of headache symptoms meeting migraine criteria. Group D with symptoms of rhinosinusitis that develop late in the course of migraine after criteria for IHS migraine are met. Group E with IHS migraine, without sinus symptoms associated with migraine.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Group A: no history or migraine, self-described sinus headache or symptoms of allergic rhinosinusitis
Exclusion Criteria:
More than 15 headache days per month
United States, Missouri | |
Clinvest, Inc. | |
Springfield, Missouri, United States, 65807 |
Principal Investigator: | Roger K Cady, MD | Clinvest, Inc. |
Study ID Numbers: | Evaluation-Histamine,CGRP,VIP, CAPSS-321 |
Study First Received: | September 13, 2005 |
Last Updated: | February 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00208065 |
Health Authority: | United States: Food and Drug Administration |
migraine biological markers rhinosinusitis |
CGRP histamine VIP |
Pseudoephedrine Otorhinolaryngologic Diseases Almotriptan Central Nervous System Diseases Headache Disorders, Primary Sinusitis Brain Diseases Serotonin Headache Disorders Histamine Naphazoline |
Oxymetazoline Respiratory Tract Diseases Respiratory Tract Infections Guaifenesin Phenylephrine Migraine Disorders Headache Histamine phosphate Ephedrine Phenylpropanolamine |
Serotonin Agonists Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Paranasal Sinus Diseases Nervous System Diseases Physiological Effects of Drugs Histamine Agents Anti-Asthmatic Agents Central Nervous System Stimulants |
Cardiovascular Agents Nose Diseases Pharmacologic Actions Nasal Decongestants Serotonin Agents Histamine Agonists Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |