NCT03926273

Brief Summary

Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 18, 2019

Last Update Submit

April 22, 2019

Conditions

Keywords

epilepsyserum ghrelinurine ghrelin

Outcome Measures

Primary Outcomes (2)

  • Serum ghrelin in Adult Epileptic Patients

    evaluation of the effect of Serum ghrelin in adult epileptic patients and in their response to anti- epileptic drugs

    6 months

  • Urine ghrelin in Adult Epileptic Patients

    evaluation of the effect of Urine ghrelin in adult epileptic patients and in their response to anti- epileptic drugs

    6 months

Study Arms (2)

group 1

Epileptic participants group consisted of 40 adults (15 females and 25 males) clinically and electrophysiological were diagnosed according to the international league against epilepsy classification 2010.

group 2

Control group consisted of 40 adults (16 females and 24 males) non - epileptic healthy subjects.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The present study was a case control type. All patients were selected from out- patient clinic of Neurology department, Zagazig university hospitals, Sharkia Governorate, Egypt in the period from July 2018 to January 2019.

You may qualify if:

  • All participants were included if their age more than or equal to 18 years. Body mass index \< 30 kg/m2, total cholesterol \< 200mg/dl, serum triglycerides \< 200 mg/dl and random blood glucose level \< 126 mg/dl.

You may not qualify if:

  • Participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders).
  • Females with irregular menstrual cycle or on estrogen therapy (7).
  • Participants with organic cerebral lesion that was detected on cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nageeb

Zagazig, Sharqia Province, 002, Egypt

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • nageeb rania, PI

    zagazig U

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 24, 2019

Study Start

June 1, 2018

Primary Completion

January 30, 2019

Study Completion

February 5, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Access Criteria
after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
More information

Locations