Back to resultsEffect of GABA on ADHD and Seizures in Children With Epilepsy.
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
GABA
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Epilepsy
- ADHD
Exclusion Criteria:
- Epilepsy without ADHD
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Before treatment
After treatment
Arm Description
no intervention
GABA
Outcomes
Primary Outcome Measures
Number of seizures
Number of seizures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04144439
Brief Title
Effect of GABA on ADHD and Seizures in Children With Epilepsy.
Official Title
Effect of Gamma Aminobutyric Acid on ADHD and Seizures in Children With Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effect of GABA on ADHD and seizures in Children with epilepsy.
Detailed Description
Effect of Gamma aminobutyric acid on ADHD and seizures in Children with epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Before treatment
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
After treatment
Arm Type
Active Comparator
Arm Description
GABA
Intervention Type
Drug
Intervention Name(s)
GABA
Other Intervention Name(s)
Gamma amino butyric acid
Intervention Description
Gamma amino butyric acid
Primary Outcome Measure Information:
Title
Number of seizures
Description
Number of seizures
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Epilepsy
ADHD
Exclusion Criteria:
Epilepsy without ADHD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief abd-elsalam, ass. prof.
Phone
00201147773440
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, Lecturer
Organizational Affiliation
Lecturer of Pediatrics - Kafr Elsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, Msc
Phone
00201009221243
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of GABA on ADHD and Seizures in Children With Epilepsy.
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