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

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ClinicalTrials.gov Identifier: NCT00208065
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 6, 2009
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Clinvest

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date May 6, 2009
Study Start Date  ICMJE May 2004
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00208065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers
Official Title  ICMJE Evaluation of Histamine, CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to "Sinus" Symptoms
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Sinusitis
Intervention  ICMJE Drug: almotriptan or pseudoephedrine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208065
Other Study ID Numbers  ICMJE Evaluation-Histamine,CGRP,VIP
CAPSS-321
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Clinvest
Collaborators  ICMJE Ortho-McNeil Neurologics, Inc.
Investigators  ICMJE
Principal Investigator: Roger K Cady, MD Clinvest, Inc.
PRS Account Clinvest
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP