Comparison of effectiveness and safety of nitrazepam versus topiramate in resistant Infantile Epileptic Spasms Syndrome: An open-label randomized controlled trial.

Postgraduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•1.Children should be fulfilling the diagnostic criteria of IESS (ILAE 2022)
•2.Male or female, age range 6-30 months at enrollment.
•3.Failed to achieve the cessation of epileptic spasms on two of three first-line therapies (ACTH, oral steroids, vigabatrin therapy) or failure to achieve the cessation of epileptic spasms on one of three first-line therapies (ACTH, oral steroids, vigabatrin therapy) when other two options were either not feasible or considered not suitable by treating neurologists or declined by parents.
•4.Within six weeks of failing on hormonal therapy and/or vigabatrin therapy

•1. Parents decline to participate in the study.
•2. Known contraindications for topiramate or nitrazepam (glaucoma, renal stone, liver disease)
•3. Known allergy to topiramate or nitrazepam.
•4. Co-intervention with another anti-seizure medication (ASM) in the last two weeks
•5.Proven or suspected cases of neurometabolic or neurodegenerative disorder
•6.Known history of aspiration pneumonia in last 3 months
•7.Weight below 3 kg

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