Zolmitriptane as Prophylaxis for Chilhood Migraine

October 13, 2023 updated by: Sherief Abd-Elsalam, Tanta University

Zolmitriptane as Prophylactic Therapy Childhood Migraine

zolmitriptane can be tried as prophylactic therapy of childhood migraine

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: abeer salamah, ass prof

Study Locations

  • Egypt
    • Kafrelsheikh
      • Tanta, Kafrelsheikh, Egypt
        • Recruiting
        • Kafrelsheikh University
        • Contact:
          • abeer salamah, lecturer
          • Phone Number: 0201009221243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

children with migraine -

Exclusion Criteria:

those who suffer from ischemic heart disease , or who have allergy to any of drugs used

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: zolmitriptane
zolmitriptane tablet daily
Drug: zolmitriptanee
zolmitriptane tablet daily
Other Names:
  • zolmitriptane tablet
Active Comparator: topiramate
topiramate tablet daily
Drug: topiramate
topiramate once daily
Other Names:
  • topiramate tablet
Active Comparator: valproate
valproate once daily
Drug: Valproate
valproate once daily
Other Names:
  • Valproate tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number and severity of migraine attacks
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Abeer Salamah, ass prof, kafrelsheikh university- egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • migraine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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