| CTRI Number |
CTRI/2021/03/032317 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"A clinical trial to study the effect of fenofibrate or placebo supplementation along with antiepileptic therapy in persons with epilepsy" |
|
Scientific Title of Study
|
"Fenofibrate as adjuvant therapy in persons with active epilepsy: a double blind, randomized, placebo- controlled study" |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5009, Convergence block, Dept. of Pharmacology, AIIMS New Delhi-110029, Delhi, India
-
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5009, Convergence block, Dept. of Pharmacology, AIIMS New Delhi-110029, Delhi, India
-
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mendapara Nipaben Harjivanbhai |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 5003D, Convergence Block, Dept. of pharmacology, AIIMS New Delhi-110029, Delhi, India
-
New Delhi
DELHI
110029
India |
| Phone |
9265298442 |
| Fax |
|
| Email |
nipa.mendapara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology |
| Address |
AIIMS, New Delhi |
| Type of Sponsor |
Government 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 |
| Dr Sudhir Chandra Sarangi |
Department of Pharmacology and Neurology |
Room No. 4 and 5, Neurology OPD, C.N. Center.
South
DELHI |
01126549259
scsarangi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenofibrate |
Patients of Fenofibrate arm will receive oral fenofibrate supplementation for 6 months (fenofibrate tablet 145 mg once a day for 6 months) along with ongoing antiepileptic drugs |
| Comparator Agent |
Matching Placebo |
Patients of placebo control arm will receive a matching placebo (as per the equivalent dose of fenofibrate) along with ongoing antiepileptic drugs for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed persons with active epilepsy (PWE) with at least 2 seizures in the last 3 months
2. Either male or female subject of 18 to 50 years old age
3. Pharmacoresistance to at least one tolerated and appropriately chosen and used AED schedules to achieve sustained seizure freedom
4. Patient ready to give informed consent
5. Ability to maintain seizure diary
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or seeking pregnancy and nursing mother
2. Patient undergoing AED tapering
3. Patient on a statin or HMG Co-A reductase inhibitor
4. Patient with active liver disease or persistent liver dysfunction
5. Patient with severe renal impairment or undergoing dialysis
6. Patient with gallstone or biliary diseases
7. Patient with known cardiac diseases, diabetes, and hypothyroidism
8. The patient refuses to give informed consent
9. Patienton any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole, etc.) or with fenofibrate (e.g. coumarin anticoagulants, bile acid-binding resins, immunosuppressants, colchicine, diuretics, hormonal contraceptives, and beta-blockers, etc.)
10. Patient on the drug known to alter seizure threshold (e.g. INH, theophylline, metronidazole, etc.)
11. A person with known hypersensitivity to fenofibrate
12. Poor compliance with AEDs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the percentage change in seizure frequency after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs. |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To find out the rate of drug responder after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs. |
2 years |
| 2. To find out the effect on the quality of life using QOLIE-10 questionnaire |
2 Years |
3. To assess safety outcomes
a. Complete Blood Counts (CBC), Liver Function Test (LFT), Renal Function Test (RFT), and Lipid profile
b. Muscular weakness or myopathy by clinical assessment using handgrip dynamometer and creatinine phosphokinase level
c. Body Composition Analysis using Bioelectrical Impedance Body Composition Analyzer (BIA)
d. Adverse Drug Reactions (ADRs) monitoring using Liverpool Adverse Events Profile (LAEP) score
|
2 Years |
| 4. To assess the effect on oxidative stress parameters i.e. serum malondialdehyde (MDA), reduced glutathione (GSH) level |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
28/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Treatment with antiepileptic drugs (AEDs) may reduce symptoms of seizures but does not influence the course of the disease. Hence, the current study aims to determine the adjuvant role of fenofibrate therapy for 6 months on seizure control, metabolic status, and quality of life in persons with epilepsy (PWE). This study will be a double-blind placebo-controlled trial and will be conducted upon PWE. Patients of both groups will be followed-up at 2 and 6 months of supplementation and all the parameters assessed in the baseline will be re-evaluated. Any adverse events during the intervention will be monitored and reported to corresponding authorities.
|