| CTRI Number |
CTRI/2025/07/091646 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Case-series |
| Study Design |
Other |
|
Public Title of Study
|
ADVERSE DRUG REACTIONS (ADRs) TO LEVETIRACETAM (LEV): A CASE SERIES AND CLINICAL INSIGHTS |
|
Scientific Title of Study
|
ADVERSE DRUG REACTIONS (ADRs) TO LEVETIRACETAM (LEV): A CASE SERIES AND CLINICAL INSIGHTS |
| 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 PRIYANKA S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRIYANKA S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRIYANKA S |
| Designation |
Associate Professor |
| Affiliation |
KIMS, Bangalore |
| Address |
Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KIMS, Bangalore |
| Address |
Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, |
| Type of Sponsor |
Private 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 |
| Priyanka S |
KIMS, Bangalore |
Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9844093100
drpriyanka110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS, IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. To report three probable cases of rare and unexpected adverse drug reactions with Levetiracetam (LEV)
2. To do ADR causality assessment of all the three cases.
3. Patients on LEV treatment who have developed adverse drug reactions. |
|
| ExclusionCriteria |
| Details |
Patients not treated with Levetiracetam. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To report three probable cases of rare and unexpected adverse drug reactions with Levetiracetam (LEV)
2. To do ADR causality assessment of all the three cases.
|
1. To report three probable cases of rare and unexpected adverse drug reactions with Levetiracetam (LEV)
2. To do ADR causality assessment of all the three cases within 10 days to 1 month of taking the drug
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for other Adverse drug reactions due to the drug Levetiracetam |
10 days & 1 month |
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
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)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
All three adverse drug reactions to Levetiracetam drug, are unexpected and rare. The main aim of presenting this case series is to disseminate existing and newly gained knowledge about the side-effect profile of LEV., which will help in identifying some serious and preventable ADRs, and thus improve patient safety and outcomes. |