Nitrazepam versus Topiramate in Resistant Infantile Spasms

Phase 3

Completed

• Conditions: Other generalized epilepsy and epileptic syndromes,

• Registration Number: CTRI/2023/06/053933
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

’Infantile spasms’ is difficult-to-treat epilepsy. The initial treatment options are hormonal therapy and vigabatrin therapy. Once these are failed, there are limited therapeutic choices, including oral nitrazepam and topiramate. There is a lack of quality comparative data for the effectiveness of nitrazepam versus topiramate in children with resistant epileptic spasms. The present study will compare the effectiveness of nitrazepam versus topiramate in a randomized, controlled manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-29
• Study Completion: 2024-12-30
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• Parents decline to participate in the study.
• Known contraindications for topiramate or nitrazepam (glaucoma, renal stone, liver disease) 3.
• Known allergy to topiramate or nitrazepam.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complete cessation of epileptic spasms	6-10 weeks

Secondary Outcome Measures

Name	Time	Method
Electroclinical response	6-10 weeks
Time to achieve cessation of spasms	Day 1-week 10
50% reduction of epileptic spasms	6-10 weeks
Heart rate variability	10 weeks
Treatment emergent adverse events	Day 1-10 weeks
Resolution of hypsarrhythmia	6 weeks
QUALIN Score	10 weeks
Tolerability (retention rates for antiseizure medication)	10 weeks

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Reserach, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Reserach, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Jitendra Kumar Sahu

Principal investigator

7087009202

jsh2003@gmail.com