| CTRI Number |
CTRI/2017/12/010835 [Registered on: 11/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of blood levels of levetiracetam in patients with fits |
|
Scientific Title of Study
|
Therapeutic drug monitoring of levetiracetam to individualize drug therapy in patients with epilepsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Muranjan |
| Designation |
Professor |
| Affiliation |
KEM Hospital |
| Address |
Department of Pediatrics
KEM Hospital
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
muranjanmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Muranjan |
| Designation |
Professor |
| Affiliation |
KEM Hospital |
| Address |
Department of Pediatrics
KEM Hospital
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
muranjanmamta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Gangurde |
| Designation |
Masters Student |
| Affiliation |
KEM Hospital |
| Address |
Department of Pediatrics
KEM Hospital
Mumbai
505, 5th floor "Bhagirathi Vishwa" Shirgaon Apte Wadi, Badlapur East
Thane district
Post code- 421503
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
aishwaryagangurde7@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEM Hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
KEM Hospital |
| Address |
Parel, Mumbai 400012 |
| 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 Mamta Muranjan |
KEM Hospital |
Pediatric Research Laboratory, 2nd floor, above ward 17/18, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
02224107645
02224107645
muranjanmamta@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Epilepsy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients on Levetiracetam for at least one year |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seizure control |
At one month, six months and one year when they come for blood level estimation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with good seizure control, levels in patients with renal dysfunction |
Monthly for the first six months after study initiation and six monthly subsequently |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2017 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Levetiracetam is a second line anti epileptic drug. In the last few years, its use has expanded considerably. However, very few centres estimate blood levels to individualize drug therapy in patients with epilepsy. Hence this study was planned to set up and validate a HPLC method for estimation of Levetiracetam and subsequently use Therapeutic Drug Monitoring to individualize treatment |