| CTRI Number |
CTRI/2024/10/075501 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| 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 epilepsy in adolescent girls |
|
Scientific Title of Study
|
Comparison of efficacy and tolerability of levetiracetam and valproate for newly diagnosed generalised and unclassifiable epilepsy in adolescent girls aged 10-18 years: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suthiraj S |
| Designation |
DM (Pediatric Neurology) resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
6th floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9037158652 |
| Fax |
|
| Email |
suthiraj.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
6th floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RISHIKESH |
| Address |
6th floor, Department of Pediatrics
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Virbhadra Road, Rishikesh, Uttarakhand- 249203, India |
|
|
Primary Sponsor
|
| Name |
Dr Suthiraj S |
| Address |
6th Floor, Department of Pediatrics, All India Institute of Medical Sciences,Virbhadra Road, Rishikesh, Uttarakhand- 249203, India |
| 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 |
All India Institute of Medical Sciences, Rishikesh |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levetiracetam |
Levetiracetam tablet (500 mg) orally twice daily for 24 weeks |
| Intervention |
Valproate |
Valproate tablet (500 mg) orally twice daily for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
1.Newly diagnosed case of generalized or unclassifiable epilepsy
2.History of at least one convulsive seizure within previous one month |
|
| ExclusionCriteria |
| Details |
1. Parents not providing informed consent
2. Adolescent suffering fromc hronic hepatic or renal disease
3. Only acute symptomatic seizures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of participants with seizure freedom |
At 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of participants with any adverse effect due to study medication |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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 3 |
|
Date of First Enrollment (India)
|
31/10/2024 |
| 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="2"
Months="0"
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
|
In this RCT we want to compare the efficacy and tolerability of two commonly used anti-seizure medications; valproate and levetiracetam in adolecsent girls with generalized and unclassifiable epilepsy aged 10-18 years. Both drugs will be administered to participants for 24 weeks and we will compare the number of patienst with seizure freedom and adverse effects in both groups. |