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Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208065
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 6, 2009
Ortho-McNeil Neurologics, Inc.
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Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Sinusitis Drug: almotriptan or pseudoephedrine Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Histamine, CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to "Sinus" Symptoms
Study Start Date : May 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Primary Outcome Measures :
  1. Baseline histamine, CGRP and VIP levels in saliva of 5 groups of subjects (A-Control group, B-Rhinosinusitis, C-Migraine with early sinus symptoms, D-Migraine with late sinus symptoms, E-Migraine without sinus symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Group A: no history or migraine, self-described sinus headache or symptoms of allergic rhinosinusitis

    • Group B: history of chronic recurrent rhinosinusitis without infection
    • Group C, D, and E: fulfill criteria for IHS migraine
    • Group C and D: fulfill protocol criteria for sinus symptoms associated with migraine
    • Group E: fulfill criteria for IHS migraine and no history of sinus symptoms
    • Age 18-65, male or female
    • Must be in good health
    • If female, postmenopausal at least 1 yr or hysterectomy or tubal ligation or be incapable of pregnancy or practice protocol listed method of contraception or have negative urine pregnancy test at Visit 1
    • Able to understand and communicate with study observer
    • Able to take oral medication and adhere to and perform study procedures
    • Able to read and comprehend written instructions and willing to complete all procedures
    • Willingness to participate by signing Informed Consent

Exclusion Criteria:

  • More than 15 headache days per month

    • Pathology of the salivary glands such as sialadenitis
    • History of hypersensitivity to pseudoephedrin in subjects assigned to Group B or to any triptan-like medication in Group A, C, D, and E.
    • Subjects with diabetes, salivary gland tumors, liver disease, alcoholism, and/or neuropathy
    • Pregnant or nursing
    • Subjects with any condition that would alter the content of the saliva
    • Subjects with any condition that would interfere with the conduct of the study
    • Subjects who currently use medications contraindicated by use of almotriptan
    • Subjects who currently use anti-inflammatory medication
    • History of drug or alcohol abuse that would interfere with the study
    • Subjects who have received an investigational drug or used an investigational device within 30 days of enrollment or previously participated in CAPSS-321
    • Employees of the investigator, study center, or sponsor with direct involvement in the study as well as family members of the employees or the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208065

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United States, Missouri
Clinvest, Inc.
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Ortho-McNeil Neurologics, Inc.
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Principal Investigator: Roger K Cady, MD Clinvest, Inc.

Layout table for additonal information Identifier: NCT00208065     History of Changes
Other Study ID Numbers: Evaluation-Histamine,CGRP,VIP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 6, 2009
Last Verified: May 2009
Keywords provided by Clinvest:
biological markers
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants