NCT04623203

Brief Summary

Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 22, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 4, 2020

Last Update Submit

November 9, 2020

Conditions

Keywords

HeadacheMigraineTension Type HeadacheAdolescentsOutcome

Outcome Measures

Primary Outcomes (1)

  • Headache diagnosis according to the ICHD-3 criteria

    The diagnosis of headache episodes at follow-up according to the ICHD-3 criteria; either Migraine or TTH.

    10 years from initial diagnosis

Study Arms (2)

children with migraine

Children that were diagnosed at the neurology clinic with migraine at the years 2007-2010. A follow up visit at 2020 of their current headache condition.

Other: No intervention

children with TTH

children that were diagnosed at the neurology clinic with TTH at the years 2007-2010. A follow up visit at 2020 of their current headache condition.

Other: No intervention

Interventions

No intervention

children with TTHchildren with migraine

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010

You may qualify if:

  • Diagnosis of migraine or TTH headache according to the ICHD-3 criteria.
  • Can describe the current headache status.

You may not qualify if:

  • \* Secondary headaches.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3104802, Israel

RECRUITING

MeSH Terms

Conditions

Migraine DisordersTension-Type HeadacheHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob GENIZI

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jacob Genizi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager pediatric neurology unit

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

November 22, 2018

Primary Completion

November 30, 2020

Study Completion

December 30, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations