| CTRI Number |
CTRI/2017/11/010605 [Registered on: 23/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparsion of levetiracetam and sodium valproate mono therapy in childhood epilepsy
|
|
Scientific Title of Study
|
Open label randomised comparison of levetiracetam and sodium valproate monotherapy in childhood epilepsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Bhayana |
| Designation |
Post graduate student |
| Affiliation |
University college of medical sciences |
| Address |
Department of paediatrics , Mch building , guru tegh Bahadur hospital
East
DELHI
110095
India |
| Phone |
9582026730 |
| Fax |
|
| Email |
swatibh1312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Bhayana |
| Designation |
Post graduate student |
| Affiliation |
University college of medical sciences |
| Address |
department of paediatrics , guru tegh Bahadur hospital
East
DELHI
110095
India |
| Phone |
9582026730 |
| Fax |
|
| Email |
swatibh1312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANju Aggarwal |
| Designation |
PROFESSOR |
| Affiliation |
University college of medical sciences |
| Address |
Department of paediatrics , guru tegh Bahadur hospital
East
DELHI
110059
India |
| Phone |
9910329791 |
| Fax |
|
| Email |
aanju67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of paediatrics , UCMS and GTB hospital , delhi |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NULL |
| Type of Sponsor |
Other [NULL ] |
|
|
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 Swati Bhayana |
Guru tegh Bahadur hospital |
university college of medical sciences and guru tegh Bahadur hospital
East
DELHI |
9582026730
swatibh1312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee-human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
newly diagnosed childhood epilepsy , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed focal motor or generalised epilepsy |
|
| ExclusionCriteria |
| Details |
1.Children who are on anti epileptic for more than 15 days
2.Children with congenital anomalies or developmental delay or microcephaly
3.Acute head trauma or post traumatic epilepsy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment will be considered successful if there is no repeat seizure activity for 6 months |
Treatment will be considered successful if there is no repeat seizure activity for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Side effect profile of the patients in each group
2.Achievement of therapeutic drug levels at steady state and 6 months
3.Time to first seizure after steady state of drug |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2017 |
| 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="1"
Months="2"
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 has proven efficacy in childhood epilepsy. Its intravenous use has been recommended in convulsive status epilepticus. Oral levetiracetam is safe and efficacious in various childhood epilepsies. Its use as monotherapy has been suggested for partial seizures and generalised tonic clonic seizures. There is still a need for well designed trials to justify the widespread use of levetiracetam monotherapy in children. Objectives: Primary To compare the efficacy of levetiracetam and sodium valproate in childhood epilepsy by comparing repeat seizures for 6 months. Secondary 1.To compare side effect profile of levetiracetam and valproate 2.To compare the retention rates of levetiracetam and valproate 3.To compare time to first repeat seizure 4.To compare drug levels at steady state (4 day for leveteracitam and 7th day for valproate). STUDY SETTING The study will be conducted in Department of Pediatrics, GTB hospital and Department of Neuropsycopharmacology, IHBAS, Delhi. An approval from the ethics committee will be obtained PARTICIPANTS Children aged 3 to 12 years presenting with newly diagnosed focal motor or generalized epilepsy OUTCOME VARIABLES Primary outcome variable- Treatment will be considered successful if there is no repeat seizure activity for 6 months. Secondary outcome variable- - Side effects profile of the patients in each group
- Achievement of therapeutic drug levels at steady state and 6 months
- Time to first seizure after steady state of drug
|