| CTRI Number |
CTRI/2024/07/070210 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| 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 the Effectiveness and Safety of Once-Daily Brivaracetam for Drug-Resistant Focal Onset Epilepsy |
|
Scientific Title of Study
|
Post approval observational study for the assessment of effectiveness and safety of once a daily sustained release formulation of BRivarACetam in drug rEsisTance focal onset epilepsy |
| Trial Acronym |
BRACkET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2402001_Version01_11Mar24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagyadan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Department of Neurology, Brain and nerve Clinic |
| Address |
Department of Neurology,
Brain and Nerve Clinic
606, Copper Leaf Complex,
Nr. Jain Temple, Bhuyagdev Cross Roads
Sola Road, Ahmedabad
Ahmadabad
GUJARAT
380062
India |
| Phone |
8980011822 |
| Fax |
|
| Email |
bhagyadhan30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyadan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Department of Neurology, Brain and nerve Clinic |
| Address |
Department of Neurology, Brain and Nerve Clinic
606, Copper Leaf Complex,
Nr. Jain Temple, Bhuyagdev Cross Roads
Sola Road, Ahmedabad
GUJARAT
380062
India |
| Phone |
8980011822 |
| Fax |
|
| Email |
bhagyadhan30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KrishnaPrasad Korukonda |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
07069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd.,
Torrent House,
Ashram Road - Navrangpura,
Ahmedabad - 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd.,
Torrent House,
Ashram Road - Navrangpura,
Ahmedabad - 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Bhagyadan Patel |
Brain and Nerve Clinic |
Department of Neurology,
Brain and Nerve CLinic, 606, Copper Leaf Complex, Nr Jain Temple, Sola Road, Ahmedabad
Ahmadabad
GUJARAT |
8980011822
bhagyadhan30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients with:
1. Partial onset seizures in patients 16 years of age and older
2. Patients diagnosed with epilepsy and treated with Brivaracetam SR tablets |
|
| ExclusionCriteria |
| Details |
Hypersensitive to Brivaracetam SR tablets or any of the ingredients in medicine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Switching pattern amongst ASMs
2. Reduction in seizure frequency at baseline
3. Greater than or equal to 50 percent Responder rate
4. Seizure freedom |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety profile of BRV SR in patients with FoS with or without secondary generalized tonic- clonic seizures |
At 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="6000"
Sample Size from India="6000"
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)
|
19/07/2024 |
| 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="4"
Days="14" |
|
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
|
Study design: Post Approval Observational Studies (PAOS) Objective: To assess effectiveness & safety of Brivaracetam -SR Once Daily in partial seizure. Duration of study: 26 Weeks Criteria for evaluation: Change in seizure frequency, Responder Rates, Seizure freedom |