Trial of Prednisolone (corticosteroid) in drug resistant epilepsy

Phase 3

Conditions: Health Condition 1: G409- Epilepsy, unspecified

Registration Number: CTRI/2021/02/030974

Lead Sponsor: Dr Mamta Bhushan Singh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br/ ><br>Timepoint: 12 months;Proportion of patients in each arm having at least 50% reduction in seizure frequency assessed at 6 months follow up <br/ ><br>Timepoint: 6 months;Safety outcome/ Proportion of patients with adverse events during scheduled or unscheduled follow ups:Timepoint: 12 weeks