NCT06089356

Brief Summary

zolmitriptane can be tried as prophylactic therapy of childhood migraine

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_4

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

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 13, 2023

Last Update Submit

October 13, 2023

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • number and severity of migraine attacks

    6 months

Study Arms (3)

zolmitriptane

ACTIVE COMPARATOR

zolmitriptane tablet daily

Drug: zolmitriptanee

topiramate

ACTIVE COMPARATOR

topiramate tablet daily

Drug: topiramate

valproate

ACTIVE COMPARATOR

valproate once daily

Drug: Valproate

Interventions

zolmitriptaneeDRUG

zolmitriptane tablet daily

Also known as: zolmitriptane tablet
zolmitriptane
topiramateDRUG

topiramate once daily

Also known as: topiramate tablet
topiramate
ValproateDRUG

valproate once daily

Also known as: Valproate tablet
valproate

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with migraine -

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Tanta, Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

TopiramateValproic Acid

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Abeer Salamah, ass prof

    kafrelsheikh university- egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

abeer salamah, ass prof

CONTACT

00201009221243abeersalamah84@yahoo.com

abeer salamah, ass prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 18, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)