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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• ClinicalTrials.gov Identifier: NCT00208065 History of Changes
• Other Study ID Numbers: Evaluation-Histamine,CGRP,VIP; CAPSS-321
• First Posted: September 21, 2005
• Last Update Posted: May 6, 2009
• Last Verified: May 2009

Keywords provided by Clinvest:

migraine; biological markers; rhinosinusitis; CGRP; histamine; VIP

Additional relevant MeSH terms:

Sinusitis; 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; Pseudoephedrine; Ephedrine; Histamine; Histamine phosphate; Almotriptan; 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