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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Clinvest
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Almotriptan; Ephedrine; Histamine; Histamine phosphate; Pseudoephedrine

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