Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers - Full Text View

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:

MedlinePlus related topics: Dietary Fiber Migraine

Drug Information available for: Ephedrine Hydrochloride Histamine Histamine phosphate Histamine dihydrochloride Pseudoephedrine Ephedrine sulfate Pseudoephedrine hydrochloride Almotriptan

U.S. FDA Resources

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 (Adult)
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


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:


Migraine Disorders Sinusitis 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 Histamine phosphate Ephedrine	Almotriptan Pseudoephedrine 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

ClinicalTrials.gov processed this record on September 26, 2016