| CTRI Number |
CTRI/2024/06/068290 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Brivaracetam drug in managing seizures |
|
Scientific Title of Study
|
Case cohort, Cross–sectional study to Assess clinical efficacy and safety of Brivaracetam in patients with primary GENERALised tonic-clonic seizures in outpatient settings of India |
| Trial Acronym |
GENERAL-I |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS2305001, Ver 06, Dated 10/04/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandan Yardi |
| Designation |
Principal Investigator |
| Affiliation |
Yardi Hospital |
| Address |
Department of Neurology, Vidya Sahakari Bank Building, 754/b, Karve Road, Karve Nagar
Pune
MAHARASHTRA
411052
India |
| Phone |
9850066005 |
| Fax |
|
| Email |
Nandanyardi@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandan Yardi |
| Designation |
Principal Investigator |
| Affiliation |
Yardi Hospital |
| Address |
Department of Neurology, Vidya Sahakari Bank Building, 754/b, Karve Road, Karve Nagar
Pune
MAHARASHTRA
411052
India |
| Phone |
9850066005 |
| Fax |
|
| Email |
Nandanyardi@proton.me |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Jain |
| Designation |
Sub Investigator |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neurology, Acharya Donde Marg, Parel,
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9930715878 |
| Fax |
|
| Email |
Neerajjain11@proton.me |
|
|
Source of Monetary or Material Support
|
| Department of Neurology, Vidya Sahakari Bank Building, 754/b, Karve Road, Karve Nagar, Pune -411052, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Soni |
Doctor Polyclinic |
Department of Neurology, Neelam Building, Opp. Poddhar Hospital, Worli
Mumbai
MAHARASHTRA |
9664320073
Dr.girishsoni@proton.me |
| Dr Rahul Kulkarni |
Mastishka Neurology Clinic |
Department of Neurology, 1050, 4th floor, Akshay Centre, Dadawadi, Shukrawar Peth,
Pune
MAHARASHTRA |
9822012588
dr.rahulk007@proton.me |
| Dr Neeraj Jain |
Seth GS Medical College and KEM Hospital |
Department of Neurology, Acharya Donde Marg, Parel,
Mumbai
MAHARASHTRA |
9930715878
Neerajjain11@proton.me |
| Dr Nandan Yardi |
Yardi Hospital |
Department of Neurology, Vidya Sahakari Bank Building, 754/b, Karve Road, Karve Nagar
Pune
MAHARASHTRA |
9850066005
Nandanyardi@proton.me |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) Seth GS Medical College and KEM Hospital |
Submittted/Under Review |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than or equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Valproate monotherapy upto 1500mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to valproate.
2) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Levetiracetam monotherapy upto 1000mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to levetiracetam.
3) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing behavioural adverse effects with levetiracetam and requiring treatment replacement with brivaracetam.
4) Clinical cases receiving brivaracetam for PGTCS with follow-up data for 12 weeks. |
|
| ExclusionCriteria |
| Details |
1) Hypersensitivity to Brivaracetam
2) Cases with structural lesion, diagnosis of Lennox Gastaut Syndrome, JAE, CAE and,or JME.
3) Lack of EEG corroboration
4) Cases with preceding or pre existing unstable medical, psychiatric or cardiovascular condition that could jeopardize or would compromise the subjects ability to participate in this study.
5) Cases without 12 weeks follow up data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Percent change in Seizure frequency every month at 12W based on patient diary.
2) Percent change in Seizure frequency from combined baseline to 12W for patients with GTCS. |
Baseline, 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| More than equal to 50% responder rate in PGTCS frequency per month |
Baseline, 4 and 12 weeks |
| Seizure freedom rate |
12 weeks |
| Physician Assessment of Effectiveness |
12 weeks |
| Adverse event rate for treatment naïve or uncontrolled cases |
4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
14/06/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an Investigator initiated, case cohort, cross-sectional, multi-center, single arm, open-label, clinical study to evaluate clinical efficacy and safety of Brivaracetam as initial add-on therapy in difficult-to-treat pGTCS receiving valproate or levetiracetam monotherapy.
The study drug is Brivaracetam oral tablets of doses 25 mg, 50 mg, 75 mg, 100 mg. Total cases will be 150 patients across India. Study visits: Baseline, Week 4, Week 12.
|