| CTRI Number |
CTRI/2024/06/068394 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
NIL |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of Brivaracetam in managing seizures |
|
Scientific Title of Study
|
To assess the safety and effectiveness of Brivaracetam in the management of focal and secondary generalized tonic clonic seizures through an observational, multicenter study |
| Trial Acronym |
BEAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshuti Shah |
| Designation |
Principal Investigator |
| Affiliation |
Department of Neurology, 3rd Floor, Rudra Arcade |
| Address |
Department of Neurology, 3rd Floor, Rudra Arcade, Opp. Traffic Helmet, Drive-in Road, Memnagar, Ahmedabad,
Ahmadabad
GUJARAT
380052
India |
| Phone |
9825074703 |
| Fax |
|
| Email |
dr.harshutishah@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshuti Shah |
| Designation |
Principal Investigator |
| Affiliation |
Department of Neurology, 3rd Floor, Rudra Arcade |
| Address |
Department of Neurology, 3rd Floor, Rudra Arcade, Opp. Traffic Helmet, Drive-in Road, Memnagar, Ahmedabad,
GUJARAT
380052
India |
| Phone |
9825074703 |
| Fax |
|
| Email |
dr.harshutishah@proton.me |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprasad K |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura,
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
| 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 Harshuti Shah |
Rajvee Ortho Spine And Child Neuro Hospital |
Department of Neurology, 3rd Floor, Rudra Arcade, Opp. Traffic Helmet, Drive-in Road
Ahmadabad
GUJARAT |
9825074703
dr.harshutishah@proton.me |
|
|
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: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1) Male or female patients with Partial onset seizures 16 years of age and older with epilepsy.
2) Patients diagnosed with epilepsy and treated with brivaracetam sustained release tablets.
|
|
| ExclusionCriteria |
| Details |
Patients allergic to brivaracetam sustained release 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 |
| Change in Seizure Frequency |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Responders Rate |
4 weeks |
| Seizure Freedom |
4 weeks |
| Clinicians Global Impression – Efficacy Index (CGI-EI) |
4 weeks |
| Demographic pattern |
Baseline |
| Prevalence of other co-morbid conditions along with Epilepsy |
Baseline |
| Other Anti-epileptic drugs (AEDs) used along with BRV SR |
Baseline, 4 weeks |
| Safety assessments in terms of AEs |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="4530"
Sample Size from India="4530"
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)
|
16/06/2024 |
| 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="1"
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
|
This
study is done to evaluate the safety and effectiveness of Brivaracetam
sustained release tablets in Indian patients with focal
and secondary generalized tonic clonic seizures. This study is a Post Approval Observational
Study (PAOS) that will be performed throughout India across 302 sites.
Study drug is Brivaracetam
sustained release available in strengths 50 mg, 100 mg, 200 mg tablets. |