| CTRI Number |
CTRI/2023/06/053933 [Registered on: 15/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nitrazepam versus Topiramate in Resistant Infantile Spasms |
|
Scientific Title of Study
|
Comparison of effectiveness and safety of nitrazepam versus topiramate in resistant Infantile Epileptic Spasms Syndrome: An open-label randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parth Lal |
| Designation |
Junior Resident |
| Affiliation |
Advanced Pediatric Center, Postgraduate Institute of Medical Eduction and Research |
| Address |
House No 37, Sector 4B
Room 5108, Department of Pediatrics, Postgraduate Institute of Medical Eduction and Research, Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9876465573 |
| Fax |
|
| Email |
parthlal201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitendra Kumar Sahu |
| Designation |
Professor |
| Affiliation |
Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research |
| Address |
Room 5108, 5A, Advanced Pediatric Center, PGIMER, Chandigarh, India
PGIMER, Sector 12
Room 5108, 5A, Advanced Pediatric Center, PGIMER, Chandigarh, India
PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009202 |
| Fax |
|
| Email |
jsh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitendra Kumar Sahu |
| Designation |
Professor |
| Affiliation |
Advanced Pediatrics Center, Postgraduate Institute of Medical education and Research |
| Address |
Room 5108, 5A, Advanced Pediatric Center, PGIMER, Sector 12, Chandigarh, India
Room 5108, 5A, Advanced Pediatric Center, PGIMER, Sector 12, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009202 |
| Fax |
|
| Email |
jsh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India will be supporting the study by providing infrastructure and thesis grant. |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendra Kumar Sahu |
Postgraduate Institute of Medical Education and Reserach, Chandigarh |
Room 5108, 5A, Advanced Pediatrics Center, Postgraduate Institute of Medical education and Research, Sector 12, Chandigarh, India
Chandigarh
CHANDIGARH |
7087009202
jsh2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral nitrazepam |
Oral nitrazepam (5 mg) will be initiated at a dose of 0.5-1 mg/kg/day in 2 divided doses. The subsequent dose escalation will be every 6 days of 0.5/kg/day to reach a maximum dose of 3 mg/kg/day in 30 days. |
| Comparator Agent |
Oral topiramate |
Oral topiramate (25 mg tablet) will be initiated at dose of 2 mg/kg/day in 2 divided doses. The subsequent dose escalation will be every 6 days of 2mg/kg/day to reach a dose of 12 mg/kg/day in 30 days . |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
30.00 Month(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| complete cessation of epileptic spasms |
6-10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resolution of hypsarrhythmia |
6 weeks |
| 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 |
| QUALIN Score |
10 weeks |
| Treatment emergent adverse events |
Day 1-10 weeks |
| Tolerability (retention rates for antiseizure medication) |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/06/2023 |
| Date of Study Completion (India) |
30/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Awaited |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response (Others) - Not decided
- For what types of analyses will this data be available?
Response (Others) - Not decided
- By what mechanism will data be made available?
Response (Others) - Not decided
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-12-2027?
Response (Others) - Not decided
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
’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. |