Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00208065 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : May 6, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Sinusitis | Drug: almotriptan or pseudoephedrine | Phase 4 |
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 |

- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208065
United States, Missouri | |
Clinvest, Inc. | |
Springfield, Missouri, United States, 65807 |
Principal Investigator: | Roger K Cady, MD | Clinvest, Inc. |
ClinicalTrials.gov Identifier: | NCT00208065 History of Changes |
Other Study ID Numbers: |
Evaluation-Histamine,CGRP,VIP CAPSS-321 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | May 6, 2009 |
Last Verified: | May 2009 |
migraine biological markers rhinosinusitis |
CGRP histamine VIP |
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 |