| CTRI Number |
CTRI/2024/05/067011 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Drugs for focal seizures |
|
Scientific Title of Study
|
Comparison of efficacy of valproate and oxcarbazepine in children with self-limited epilepsy with centrotemporal spikes: a randomized control trial VO-SELECT trial |
| Trial Acronym |
VO-SELECT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Gupta |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
AIIMS, Rishikesh |
| Address |
6th floor, Department of Pediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
aditileeminho359@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prateek Kumar Panda |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
AIIMS, Rishikesh |
| Address |
6th Floor, Department of Pediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prateek Kumar Panda |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
AIIMS, Rishikesh |
| Address |
6th Floor, Department of Pediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Rishikesh, District-Dehradun, Uttarakhand, India, Pincode-249203 |
|
|
Primary Sponsor
|
| Name |
Aditi Gupta |
| Address |
6th floor, Department of Pediatrics, AIIMS, Rishikesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Prateek Kumar Panda |
AIIMS, Rishikesh |
6th floor, Department of Pediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oxcarbazepine |
oral tablets at a dose of 15 mg/kg/day in two dived doses daily for 12 weeks |
| Comparator Agent |
valproate |
oral tablets at a dose of 20 mg/kg/day in two dived doses daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cases of self-limited epilepsy with centrotemporal spikes |
|
| ExclusionCriteria |
| Details |
History of allergy to either study medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants who remain seizure free in each group |
At 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of participants with adverse effects related to study medication |
At 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This RCT will compare two commonly used anti-epileptic drugs valproate and oxcarbazepine in children with self-limited epilepsy with centro-temporal spikes, aged 3-14 years. This is a very common type of epilepsy in children. In this RCT, we will randomize 114 eligible cases of newly diagnosed self limited epilepsy with centro-temporal spikes to either oxcarbazepine or valproate group. While oxcarbazepine group will receive the drug at 15 mg/kg/day in two divided doses daily for 12 weeks, the participants in valproate group will receive the drug at 20 mg/kg/day in two divided doses for 12 weeks. We will compare the proportion of participants who remain seizure free at 12 weeks in both groups and also number of participants with any adverse effect in both groups. |