NCT01845051

Brief Summary

The researchers investigated the relationship between migraine and allergy. For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects. According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

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

November 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

April 29, 2013

Last Update Submit

May 1, 2013

Conditions

MigraineAllergic Rhinitis

Keywords

Migraineallergic rhinitisSpecific Immunoglobulin E (IgE)nasal symptomssigns of allergy.

Outcome Measures

Primary Outcomes (2)

  • Specific Immunoglobulin E (IgE)

    Blood samples were taken from study and control group for the determination of Specific IgE panel against six different allergens: (1) fungi, (2) grass pollens, (3) tree pollens, (4) wild herbs, (5) mite 1, (6) mite 2. For all of specific IgE panels, \<0,7 RU/ml was negative; and \>0,7 RU/ml was Positive.

    1 day

  • Nasal Symptom Scores

    Symptoms were assessed with a questionnaire for the presence and severity of allergic rhinitis (AR) symptoms on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). Symptoms of AR (Nasal discharge, nasal congestion, itching and sneezing) were graded between 0-3.

    1 day

Other Outcomes (1)

  • İnferior turbinate color and edema

    1 day

Study Arms (2)

Migraine group

Patients diagnosed with migraine

Healthy group

Healthy subjects with no migraine as control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migraine patients attending neurology clinic and healthy subjects

You may qualify if:

  • patients with migraine

You may not qualify if:

  • other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder
  • also acute and chronic sinusitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine DisordersRhinitis, Allergic

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ENT Specialist

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 3, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-05