NCT05048914

Brief Summary

Migraine headaches in children and adolescents may cause severe attacks that require abortive treatment. This study evaluated the incidence and efficacy of medications used for relieving migraine headache attacks in the pediatric population in Israel. Children 6-18 years of age who were diagnosed in our pediatric neurology clinic as having migraine headaches were enrolled into the study. Children and their parents filled in questionnaires about their response to abortive treatment two hours after use, during three acute headache attacks. The questionnaire included demographic data, baseline headache intensity, migraine-associated symptoms, medications used, and pain assessment.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

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

September 3, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

September 9, 2021

Last Update Submit

September 9, 2021

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • Migraine treatment

    improvement of headache severity

    2 hours

Interventions

IbuprofenDRUG

treatment of acute migraine attack

Also known as: acetaminophen, dipyrone

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children 6-18 years of age who were diagnosed with migraine headaches will be enrolled into the study.

You may qualify if:

  • children 6-18 years of age with migraine headaches. Need for headache abortive treatment -

You may not qualify if:

  • Secondary headache Systemic disease Mental Retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3104802, Israel

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

IbuprofenAcetaminophenDipyrone

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesAminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jacob Genizi, MD

CONTACT

97248359442jacob.genizi@b-zion.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Pediatric Neurology Unit

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 17, 2021

Study Start

September 3, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

IL(1)