NCT00208065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

May 5, 2009

Conditions

MigraineSinusitis

Keywords

migrainebiological markersrhinosinusitisCGRPhistamineVIP

Outcome Measures

Primary Outcomes (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

Interventions

almotriptan or pseudoephedrineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinvest, Inc.

Springfield, Missouri, 65807, United States

Location

MeSH Terms

Conditions

Migraine DisordersSinusitisRhinosinusitis

Interventions

almotriptanPseudoephedrine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesRhinitis

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Roger K Cady, MD

    Clinvest, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations

US(1)