| CTRI Number |
CTRI/2018/02/012248 [Registered on: 28/02/2018] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Study of effect of treatment versus no treatment on variuos parameters in children with BECTS |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effect of treatment versus no treatment on seizures, psychological, behavioral and EEG parameters in children with BECTS type of epilepsy |
|
Scientific Title of Study
|
A multicentric, randomized, prospective, open-labelled study to compare the effects of “treatment†versus “no treatment†on neuropsychological and electro-clinical parameters in Indian children with newly diagnosed BECTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita Srivastava |
| Designation |
Associate Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Pune
Department of Pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune
411043
Pune
MAHARASHTRA
411060
India |
| Phone |
9850825791 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Srivastava |
| Designation |
Associate Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Pune
Department of Pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune
411043
Pune
MAHARASHTRA
411060
India |
| Phone |
9850825791 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Srivastava |
| Designation |
Associate Professor in Pediatrics |
| Affiliation |
Bharati Vidyapeeth Medical College, Pune |
| Address |
Pune
Department of Pediatrics, 3rd floor, Bharati Hospital, Katraj, Pune
411043
Pune
MAHARASHTRA
411060
India |
| Phone |
9850825791 |
| Fax |
020-24375541 |
| Email |
kavisri1970@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical College Pune |
| Address |
Department of Pediatrics, 3rd floor, Bharati Hospital, Pune |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United Arab Emirates |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavita Srivastava |
Bharati Vidyapeeth University Medical College Pune |
Department of pediatrics, 3rd floor, Bharati hospital, Katraj, Pune
Pune
MAHARASHTRA |
9850825791
02024375541
kavisri1970@gmail.com |
| Dr Anaita Udwadia Hegde |
Jaslok Hospital, Mumbai |
Pedder Road, Mumbai
Mumbai
MAHARASHTRA |
9820186155
anaitahegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College, Pune Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children suffering from Benign Epilepsy with centro-temporal spikes ( BECTS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No treatment |
Patients randomized to no treatment group will be followed up without any treatment for the same parameters |
| Intervention |
Treatment with antiepileptic drug Valproate |
Valproate would be started to patients randomized to treatment group |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Onset of seizures after the age of 3 years
2. History of at least one typical seizure
3. Normal neurological and development history
4.Clinical and EEG criteria suggestive of BECTS according to ILAE criteria
5. No other seizure type |
|
| ExclusionCriteria |
| Details |
1. Prior neurological deficits
2. Pre-existing psychiatric conditions
3. Symptomatic etiology
4. 3 or more seizures in last 3 months
5. Already on anti-epileptics for more than a week |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in cognition ( IQ), language, behavior and academic achievement of children with newly diagnosed BECTS, between the no treatment group versus the Treatment group; from baseline to follow up over 2 years. |
3 monthly till 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) To study the clinical and the EEG profile in these children at baseline and further till 2 years
ii) To compare the seizure recurrence rates between the two groups
iii) To monitor for any adverse effects related to the drug (in treatment group).
|
3 monthly till 2 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="120"
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)
|
02/04/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/12/2017 |
| 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)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After screening for eligibility, patients will be randomized to treatment or No treatment group.
At baseline, both groups will undergo EEG, neuro-psychological and language testing. These tests will be repeated at the end of 1 and 2 years on follow up.
In the treatment group, Valproate will be started, follow up will be done 3 monthly, including for monitoring for any side effects .
In no treatment group, follow up will be done 3 monthly.
The difference in these parameters in both the groups will be studied at the end of 2 years
|