| CTRI Number |
CTRI/2024/06/068495 [Registered on: 06/06/2024] 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
|
Brivaracetam drug in treating epilepsy |
|
Scientific Title of Study
|
Treatment of Focal Seizures Patients with Brivaracetam through a Multicenter, Real-World Study: Case Cohort Analysis |
| Trial Acronym |
ROBUST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikunj R Godhani |
| Designation |
Principal Investigator |
| Affiliation |
Karunesh Neuro and Spine SUrgical Hospital |
| Address |
Department of Neurology, Karunesh Neuro and Spine SUrgical Hospital, 46/47, Indravihar Society, Nikol Gam Road, Thakkarnagar, Ahmedabad,
Ahmadabad
GUJARAT
382350
India |
| Phone |
9825941321 |
| Fax |
|
| Email |
drnikunjgodhani@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikunj R Godhani |
| Designation |
Principal Investigator |
| Affiliation |
Karunesh Neuro and Spine SUrgical Hospital |
| Address |
Department of Neurology, Karunesh Neuro and Spine SUrgical Hospital, 46/47, Indravihar Society, Nikol Gam Road, Thakkarnagar, Ahmedabad,
GUJARAT
382350
India |
| Phone |
9825941321 |
| Fax |
|
| Email |
drnikunjgodhani@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 Nikunj R Godhani |
Karunesh Neuro and Spine Surgical Hospital |
Department of Neurology, Karunesh Neuro and Spine Surgical Hospital, 46/47, Indravihar Society, Nikol Gam Road, Thakkarnagar, Ahmedabad,
Ahmadabad
GUJARAT |
9825941321
drnikunjgodhani@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
|
| Type |
Name |
Details |
| Intervention |
Brivaracetam Tablets |
Dose: Brivaracetam 25 mg, 50 mg, 100 mg, 200 mg oral tablets.
Frequency: Will be determined by treating investigator.
The tablets will be administered orally and swallowed as whole without chewing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1) Male or female patients with partial onset seizures with or without secondary generalization in patients 18 years of age and older with epilepsy.
2) Known cases brivaracetam receiving therapy for more than equal to 2 weeks.
|
|
| ExclusionCriteria |
| Details |
Patients allergic to brivaracetam 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 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Responders Rate |
4 weeks and 12 weeks |
| Seizure Freedom |
4 weeks and 12 weeks |
| Clinicians Global Impression – Efficacy Index (CGI-EI) |
4 weeks and 12 weeks |
| Quality of life |
4 weeks and 12 weeks |
| Patient’s treatment acceptability |
4 weeks and 12 weeks |
| Demographic pattern |
Baseline |
| Prevalence of other co-morbid conditions along with Focal Epilepsy |
Baseline |
| Other Anti-epileptic drugs (AEDs) used along with BRV. |
Baseline, 4 weeks and 12 weeks |
| Safety assessments in terms of AEs |
4 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="2100"
Sample Size from India="2100"
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="3"
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 planned to evaluate the safety and effectiveness of brivaracetam in Indian
patients with focal epilepsy.
- Study design: Post Approval Observational Studies (PAOS).
- Duration
of Observation: 12 weeks (At least)
- Study drug and dose: Brivaracetam
25 mg, 50 mg, 100 mg, 200 mg tablets.
|