Efficacy and safety of prednisolone as an adjunct to anti epileptic drugs in drug resistant epilepsy: A Randomized double blind placebo control study - PREDREP

Dr Mamta Bhushan Singh0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

Dr Mamta Bhushan Singh