CTRI/2024/06/068290Not yet recruitingNot Applicable
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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Not applicable
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- 1) Percent change in Seizure frequency every month at 12W based on patient diary.
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •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.
- •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.
- •Clinical cases receiving brivaracetam for PGTCS with follow-up data for 12 weeks.
Exclusion Criteria
- •Hypersensitivity to Brivaracetam 2) Cases with structural lesion, diagnosis of Lennox Gastaut Syndrome, JAE, CAE and,or JME.
- •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.
- •Cases without 12 weeks follow up data.
Outcomes
Primary Outcomes
1) Percent change in Seizure frequency every month at 12W based on patient diary.
Time Frame: Baseline, 4 weeks and 12 weeks
2) Percent change in Seizure frequency from combined baseline to 12W for patients with GTCS.
Time Frame: Baseline, 4 weeks and 12 weeks
Secondary Outcomes
- 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)
Investigators
Dr Nandan Yardi
Yardi Hospital
Study Sites (4)
Loading locations...
Similar Trials
Not yet recruiting
Unknown
To Evaluate the Safety and Performance of Mural Drug Eluting Stent .CTRI/2025/12/099358Meril Life Sciences Pvt. Ltd136
Not yet recruiting
Phase 2
A Clinical trial on Lavangapattai Kudineer in the management of Raththa moolam(Bleeding Hemorrhoids) among patients attending OPD and IPD of Government Siddha Medical College and Hospital, Palayamkottai, TirunelveliCTRI/2025/02/080709GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL40
Recruiting
Not Applicable
A Quantitative, Cross-Sectional and Observational Study to Characterize Age-Related Structural Changes in Facial Skin of Chinese Women Using Line-Field Confocal Optical Coherence Tomography (LC-OCT)NCT07415798ChinaNorm100
Completed
Phase 3
A multi-arm, open label, clinical study that will be conducted at one hospital to understand the safety and benefits of Aller GI health supplements in controlling sinusitis, rhinitis and skin allergyCTRI/2024/02/063075LIFE AVEDA100
Not yet recruiting
Phase 2
A Clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis) among patients attending OPD and IPD of Government Siddha Medical College and Hospital,PalayamkottaiCTRI/2024/06/068547GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL40