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Zolmitriptane as Prophylaxis for Chilhood Migraine

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06089356
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
12
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

zolmitriptane can be tried as prophylactic therapy of childhood migraine

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Zolmitriptane as Prophylactic Therapy Childhood Migraine
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number and severity of migraine attacks [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    children with migraine -

    Exclusion Criteria:

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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kafrelsheikh University Tanta Kafrelsheikh Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, professor, Tanta University
    ClinicalTrials.gov Identifier:
    NCT06089356
    Other Study ID Numbers:
    • Migraine
    First Posted:
    Oct 18, 2023
    Last Update Posted:
    Oct 18, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Migraine Disorders
    Topiramate
    Valproic Acid

    Study Results

    No Results Posted as of Oct 18, 2023