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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

almotriptan or pseudoephedrine

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, biological markers, rhinosinusitis, CGRP, histamine, VIP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinvest, Inc.

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00208065

First Posted

September 13, 2005

Last Updated

May 5, 2009

Sponsor

Clinvest

Collaborators

Ortho-McNeil Neurologics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00208065

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Clinvest

Collaborators

Ortho-McNeil Neurologics, Inc.

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Sinusitis

Keywords

migraine, biological markers, rhinosinusitis, CGRP, histamine, VIP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

almotriptan or pseudoephedrine

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger K Cady, MD

Organizational Affiliation

Clinvest, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinvest, Inc.

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Migraine, Sinusitis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial