Back to resultsZolmitriptane as Prophylaxis for Chilhood Migraine
Primary Purpose
Migraine
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
zolmitriptanee
topiramate
Valproate
Sponsored by
About this trial
This is an interventional prevention trial for Migraine
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 -
Sites / Locations
- Kafrelsheikh UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
zolmitriptane
topiramate
valproate
Arm Description
zolmitriptane tablet daily
topiramate tablet daily
valproate once daily
Outcomes
Primary Outcome Measures
number and severity of migraine attacks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06089356
Brief Title
Zolmitriptane as Prophylaxis for Chilhood Migraine
Official Title
Zolmitriptane as Prophylactic Therapy Childhood Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
zolmitriptane
Arm Type
Active Comparator
Arm Description
zolmitriptane tablet daily
Arm Title
topiramate
Arm Type
Active Comparator
Arm Description
topiramate tablet daily
Arm Title
valproate
Arm Type
Active Comparator
Arm Description
valproate once daily
Intervention Type
Drug
Intervention Name(s)
zolmitriptanee
Other Intervention Name(s)
zolmitriptane tablet
Intervention Description
zolmitriptane tablet daily
Intervention Type
Drug
Intervention Name(s)
topiramate
Other Intervention Name(s)
topiramate tablet
Intervention Description
topiramate once daily
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Valproate tablet
Intervention Description
valproate once daily
Primary Outcome Measure Information:
Title
number and severity of migraine attacks
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abeer salamah, ass prof
Phone
00201009221243
Email
abeersalamah84@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
abeer salamah, ass prof
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, ass prof
Organizational Affiliation
kafrelsheikh university- egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Tanta
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abeer salamah, lecturer
Phone
0201009221243
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Zolmitriptane as Prophylaxis for Chilhood Migraine
We'll reach out to this number within 24 hrs