Zolmitriptane as Prophylaxis for Chilhood Migraine | NCT06089356

Studies
Zolmitriptane as Prophylaxis for Chilhood Migraine

NCT06089356

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Oct 18, 2023Actual

Enrollment

90Estimated

Phase

Phase 4

Conditions

Migraine

Interventions

zolmitriptanee
topiramate
Valproate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2023

Last Update Posted Date

Oct 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

zolmitriptane can be tried as prophylactic therapy of childhood migraine

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
zolmitriptanee	Drug	zolmitriptane tablet daily	zolmitriptane	zolmitriptane tablet

Measure	Description	Time Frame
number and severity of migraine attacks		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with migraine -

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abeer salamah, ass prof	Contact	00201009221243		abeersalamah84@yahoo.com
abeer salamah, ass prof	Contact

Overall Officials

Name	Affiliation	Role
Abeer Salamah, ass prof	kafrelsheikh university- egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh University	Recruiting	Tanta	Kafrelsheikh		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077236	Topiramate
D014635	Valproic Acid

Ancestor Terms

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241

Browse Leaves

Not provided

Browse Branches

Not provided