Effect of GABA on ADHD and Seizures in Children With Epil... | NCT04144439

Studies
Effect of GABA on ADHD and Seizures in Children With Epilepsy.

NCT04144439

Sponsor

Sherief Abd-Elsalam

Status

Recruiting

Last Update Posted

Oct 30, 2019Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Epilepsy

Interventions

GABA

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 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

Oct 4, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 30, 2019Actual

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 29, 2019

Last Update Posted Date

Oct 30, 2019Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before treatment	No Intervention	no intervention
After treatment	Active Comparator	GABA	Drug: GABA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GABA	Drug	Gamma amino butyric acid	After treatment	Gamma amino butyric acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of seizures	Number of seizures	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epilepsy
ADHD

Exclusion Criteria:

Epilepsy without ADHD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 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
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com
sherief abd-elsalam, ass. prof.	Contact	00201147773440		sherif_tropical@yahoo.com

Overall Officials

Name	Affiliation	Role
Abeer Salamah, Lecturer	Lecturer of Pediatrics - Kafr Elsheikh University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta		35111	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
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005680	gamma-Aminobutyric Acid

Ancestor Terms

ID	Term
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided