NCT04144439

Brief Summary

Effect of GABA on ADHD and seizures in Children with epilepsy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
31mo left

Started Jul 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
Jul 2018Dec 2028

Study Start

First participant enrolled

July 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

10.4 years

First QC Date

October 4, 2019

Last Update Submit

October 29, 2019

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Number of seizures

    Number of seizures

    6 months

Study Arms (2)

Before treatment

NO INTERVENTION

no intervention

After treatment

ACTIVE COMPARATOR

GABA

Drug: GABA

Interventions

GABADRUG

Gamma amino butyric acid

Also known as: Gamma amino butyric acid
After treatment

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Epilepsy
  • ADHD

You may not qualify if:

  • Epilepsy without ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Abeer Salamah, Lecturer

    Lecturer of Pediatrics - Kafr Elsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

sherief abd-elsalam, ass. prof.

CONTACT

00201147773440sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 30, 2019

Study Start

July 1, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)