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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Clinvest
ClinicalTrials.gov Identifier:
NCT00208065
First received: September 13, 2005
Last updated: May 5, 2009
Last verified: May 2009
  Purpose

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
Migraine
Sinusitis
Drug: almotriptan or pseudoephedrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Clinvest:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: May 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208065

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

No publications provided

ClinicalTrials.gov Identifier: NCT00208065     History of Changes
Other Study ID Numbers: Evaluation-Histamine,CGRP,VIP, CAPSS-321
Study First Received: September 13, 2005
Last Updated: May 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Clinvest:
migraine
biological markers
rhinosinusitis
CGRP
histamine
VIP

Additional relevant MeSH terms:
Sinusitis
Migraine Disorders
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pseudoephedrine
Ephedrine
Histamine
Histamine phosphate
Almotriptan
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014