| CTRI Number |
CTRI/2017/04/008392 [Registered on: 21/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Seizure recurrence chance after antiepileptic drug withdrawal and its correlation with drug level and other laboratory parameters |
|
Scientific Title of Study
|
A prospective observational study to find out correlation of serum antiepileptic drug (AED) and biomarkers levels with seizure recurrence in persons with epilepsy (PWE) undergoing AED tapering |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Room no. 4012, Department of Pharmacology, AIIMS, New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
ROOM NO. 4012, DEPARTMENT OF PHARMACOLOGY, AIIMS, NEW DELHI-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Manjari Tripathi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 705, Department of Neurology, AIIMS, New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
mtripathiaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
DEpartment of Pharmacology, Room no. 4012, All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Chandra Sarangi |
All India Institute of Medical Sciences, New Delhi |
Department of Pharmacology (Room no. 4012) and Neurology (Room no. 705)
South
DELHI |
011-26549259
scsarangi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Persons with epilepsy undergoing antiepileptic drug tapering after more than 2 years of seizure free period, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed persons with epilepsy (PWE)
2. Either male or female, age more than 18 years
3. On monotherapy of AEDs (valproic acid, carbamazepine, phenytoin and levetiracetam)
4. Two years seizure freedom or longer
5. PWE going to start AED tapering
6. Patient ready to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Juvenile myoclonic epilepsy
2. Pregnant or seeking pregnancy
3. Associated neurological diseases other than epilepsy
4. Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)
5. Patient with significant hepatic and renal impairment that may require dose alteration
6. Patient on anti tubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)
7. Patient on food or dietary supplements like grape fruit juice and ginkgo biloba which are known to cause interaction with AEDs
8. Any associated psychiatric disorder
9. Any chronic inflammatory disorder (e.g. Autoimmune disorder like RA, IBD, bronchial asthma)
10. Patient refuses to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of seizure recurrence in PWE on monotherapy undergoing AED tapering with minimum 1 year follow up period |
1 year follow up period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ï‚— Correlation between the lowering of serum AED concentration with seizure recurrence in PWE on monotherapy undergoing AED tapering |
1 year follow up period |
| ï‚— Correlation of the following factors with seizure recurrence with treatment, seizure, inflammatory biomarkers- TNF alpha, IL-1 beta |
1 year follow up period |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is to see seizure recurrence in persons with epilepsy undergoing antiepileptic drug tapering and to correlate this with serum AED level and inflammatory biomarkers. This
study will find out variety of predictors i.e. factors correlated with seizure
recurrence in PWE. Though AED serum level monitoring is routinely done during
AED treatments, its scope during AED withdrawal is not established. Identifying
the association of baseline trace elements levels and cytokines levels with
seizure recurrence could have role in optimizing AED withdrawal. The actual
incidence of seizure recurrence in PWE undergoing AED tapering in a tertiary
hospital set up can be estimated. Thus the study result will aid in better
management of PWE undergoing AED withdrawal.
|