Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Prednisolone: Tablet prednisolone will be given at a dose of 1 mg/kg/day (rounded to nearest multiple of 10
maximum 60 mg/day) for a period of 6 weeks followed by gradual taper over 6 weeks along with the usual antiepileptic drugs.
Control Intervention1: Lactose: Lactose capsules will be given in similar ma
Sponsors
Dr Mamta Bhushan Singh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Drug resistant focal epilepsy with any of the following: a) Unwilling for epilepsy surgery b) Poor candidates for epilepsy surgery (including patients with more than one epileptogenic foci, non-lesional extra-temporal lobe epilepsy, those with a single focus but very close to eloquent cortex carrying a significant risk of post-operative loss of function) c) Evaluated and cleared for surgery and on the waiting list but unlikely to be operated in the next 12 months d) Post epilepsy surgery patients who have failed surgery and continue to have seizures 2. One or more unprovoked seizure(s) every week in preceding 12 weeks 3. Age > 18yrs, either gender
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI of 30 or above) 2. Diabetes (FBS >= 126, HBA1C >6.4 or h/o diabetes) 3. Uncontrolled hypertension (BP >140/90 despite being on at least one antihypertensive medication) 4. Active infection (Oropharyngeal and genital Candidiasis, fever, TLC > 11000, Urine RM showing >5 WBC/hpf or bacteria, CXR showing lymphadenopathy, infiltrations/consolidation) 5. Active TB (fever, cough for than 2 weeks, CXR showing lymphadenopathy, infiltrations/consolidation, or currently diagnosed with TB) 6. Peptic Ulcer disease: h/o severe abdominal pain and nausea, malena, hematemesis, history of peptic ulcer disease 7. Currently taking steroids for any indication 8. Currently taking immunosuppressive therapy 9. Any contraindication to systemic corticosteroid administration 10. Psychogenic Non Epileptic Seizures coexisting with epilepsy 11. Diagnosed Autoimmune epilepsy, Rasmussens Encephalopathy, West Syndrome, Dravets Syndrome, Lennox Gastaut Syndrome. 12. Pregnant/lactating woman 13. Poor compliance to ongoing Anti Epileptic Drugs 14. Not willing to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in each arm having 50% or more reduction in seizure frequency compared to baseline assessed at 12 weeks follow up.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Quality of life between baseline and at 12 weeks with Patient Weighted Quality of Life In Epilepsy: QOLIE-10-P scale in each arm.Timepoint: 12 weeks;Proportion of patients in each arm having at least 50% reduction in seizure frequency assessed at 12 months follow up Timepoint: 12 months;Proportion of patients in each arm having at least 50% reduction in seizure frequency assessed at 6 months follow up Timepoint: 6 months;Safety outcome/ Proportion of patients with adverse events during scheduled or unscheduled follow ups:Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rahul Singh Oinam
AIIMS
Outcome results
None listed