| CTRI Number |
CTRI/2019/05/018990 [Registered on: 08/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the seizure drug levetiracetam with controlled release carbamazepine in new focal seizure patients |
|
Scientific Title of Study
|
A comparative study of the safety, efficacy, quality of life outcome and pharmacoeconomics of levetiracetam with controlled-release carbamazepine in patients of new onset focal seizures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin Patiyal |
| Designation |
Junior resident |
| Affiliation |
Dr. R.P.G.M.C, Kangra at Tanda |
| Address |
Department of Pharmacology, Dr. R.P.G.M.C., Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418653777 |
| Fax |
01892267115 |
| Email |
nitin.jadu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dinesh Kansal |
| Designation |
Professor and Head |
| Affiliation |
Dr. R.P.G.M.C, Kangra at Tanda |
| Address |
Department of Pharmacology, Dr. R.P.G.M.C., Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
01892267115 |
| Email |
dinesh.kansal56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Patiyal |
| Designation |
Junior resident |
| Affiliation |
Dr. R.P.G.M.C, Kangra at Tanda |
| Address |
Department of Pharmacology, Dr. R.P.G.M.C., Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418653777 |
| Fax |
01892267115 |
| Email |
nitin.jadu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institutional sponsored |
| Address |
Dr RPGMC Kangra at Tanda |
| 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 Nitin Patiyal |
Dr Rajendra Prasad Government Medical College |
Department of Pharmacology,
Paraclinical block,
Dr Rajendra Prasad Government Medical College
Kangra at Tanda
Kangra
HIMACHAL PRADESH |
9418653777
01892267115
nitin.jadu@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: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, (2) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, (3) ICD-10 Condition: G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled-release carbamazepine |
Carbamazepine-controlled release 300 mg twice daily after adequate buildup and titrated upto 1200 mg per day depending upon seizure control.
Duration of the treatment will depend upon the clinical outcome as per neurologists opinion.
Carbamazepine is widely used anti-seizure drug despite its limited range of activity as a treatment for focal, focal-to-bilateral tonic-clonic seizures.4 Carbamazepine is iminostilbene derivative having a carbamyl group at the 5 position; this carbamyl moiety provides potent anti-seizure activity.
Carbamazepine is also a mood stabilizer and is used to treat bipolar disorder. Carbamazepine is a prototypical sodium channel-blocking anti-seizure drug that blocks voltage-gated sodium channels, responsible for the rising phase of neuronal action potentials. |
| Intervention |
Levetiracetam |
Levetiracetam 500 mg twice daily and titrated upto 3000 mg per day depending upon seizure control.
Duration of the treatment will depend upon the clinical outcome as per neurologists opinion.
Levetiracetam is the newer anti-seizure drug with better pharmacokinetic profile with the advantage of less drug interactions and has comparatively wide therapeutic range.11, 12 Levetiracetam is the S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide, and has novel mode of action by binding to synaptic vesicle protein 2A. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will include all the newly diagnosed consenting adult patients of focal seizures without any other co-morbidities |
|
| ExclusionCriteria |
| Details |
Patients not willing to give written informed consent.
Pregnant females.
Patients already on treatment with study drugs.
Patients of seizures others than focal seizures.
Patients of head trauma within past one month.
Patients with known contraindication or refractoriness to study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimal adverse drug reactions and seizure freedom |
At 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life outcome |
Before initiating treatment and at 6 months |
| Pharmacoeconomics |
At 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/05/2019 |
| Date of Study Completion (India) |
14/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
The study is being done to compare the safety, efficacy, quality of life outcome and pharmacoeconomics of levetiracetam with controlled-release carbamazepine in adult patients of new onset focal seizures. The study will be a randomized, prospective, open label, comparative interventional study. The study will be conducted in the Department of Neurology and the Department of Pharmacology at Dr. R.P.G.M.C, Kangra at Tanda which is a 500 bedded multispeciality tertiary health care centre situated in Himachal Pradesh in India. |