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CTRI Number  CTRI/2024/12/077706 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomised-Controlled Trial of Efficacy and Safety of Intramuscular Fosphenytoin Versus Intravenous Fosphenytoin for Pediatric Status Epileptics 
Scientific Title of Study   Efficacy, Safety, and Tolerability of Intramuscular Versus Intravenous Fosphenytoin for Pediatric Status Epilepticus - A Randomised-Controlled, Open-label, Non-inferiority Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavita Srivastava 
Designation  Professor in Pediatric Neurology 
Affiliation  Bharati Vidyapeeth Deemed University, Medical College and Hospital, Pune 
Address  Department of Pediatrics, Bharati Vidyapeeth Deemed University, Medical College and Hospital, Pune - 411043

Pune
MAHARASHTRA
411043
India 
Phone  9850825791  
Fax    
Email  kavita.srivastava@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Asavari Raut 
Designation  Professor in Clinical Pharmacy 
Affiliation  BVDUs Poona College of Pharmacy, Pune 
Address  Department of Pharmacy Practice, BVDUs Poona College of Pharmacy, Pune - 411038/43.

Pune
MAHARASHTRA
411043
India 
Phone  8805058493  
Fax    
Email  asawari.raut@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vaibhav Suryawanshi 
Designation  Assistant Professor in Clinical Pharmacy 
Affiliation  BVDUs Poona College of Pharmacy, Pune 
Address  Department of Pharmacy Practice, BVDUs Poona College of Pharmacy, Pune - 411038/43.

Pune
MAHARASHTRA
411043
India 
Phone  9552956860  
Fax    
Email  vaibhav.suryawanshi@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeths Bharati Hospital and Research Centre, Pune-38. 
 
Primary Sponsor  
Name  Dr Kavita Srivastava 
Address  Pediatric Neurology Unit, Department of Pediatrics, Bharati Vidyapeeths Bharati Hospital and Research Centre, Pune-Satara Road, Katraj, Pune-43. 
Type of Sponsor  Other [Individual (PI) is the primary sponsor.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavita Srivastava  Bharati Hospital and Research Centre  Pediatric Neurology Unit, Department of Pediatrics, BVDUs Bharati Hospital and Research Centre, Pune-Satara Road, Katraj, Pune-43.
Pune
MAHARASHTRA 		 9850825791

kavita.srivastava@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth Deemed University Medical College.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intramuscular Fosphenytoin (route of administration)  50 mg PE per ml fosphenytoin vial will be used. Dose: Intramuscular fosphenytoin 18-20 mg PE per kilogram will be administered, 2-4 ml at one site. Injection site: Vastus muscle (anterolateral/medial thigh - preferred site) or (ventrogluteal muscle - alternative site). 
Comparator Agent  Intravenous Fosphenytoin (route of administration)  50 mg PE per ml fosphenytoin vial will be used. Dose: Intravenous fosphenytoin 18-20 mg PE per kilogram at rate of 2 mg PE per kilogram per minute or 150 mg PE per kilogram per minute, whichever is slower will be administered.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Pediatric patients with age 2 months to 6 years, diagnosed with convulsive SE and who will be treated with consensually accepted cumulative dose of benzodiazepine (preferably midazolam nasal-spray), lasting or continue to have seizures for more than 5 minutes and no more than 30 minutes after the last dose of benzodiazepines.
The minimal adequate cumulative doses of benzodiazepines will be defined as diazepam at a dose of 0.3 mg per kilogram of body weight (administered intravenously or rectally), lorazepam at a dose of 0.1 mg per kilogram (administered intravenously), or midazolam at a dose of 0.3 mg of per kilogram (administered intramuscularly) or 0.2 mg per kilogram (administered intravenously or intranasally) for children who weighed less than 32 kg. These drugs may have been administered in divided doses, including prior to patient’s arrival in the emergency department (out-hospital SE). 
 
ExclusionCriteria 
Details  The study will exclude patients who are already on antiseizure medication/s for the long-term control of seizure. Those patients will also be randomly assigned to a treatment groups without regard to their antiseizure medication/s type.
Patients who arrive at the emergency department with one of the following conditions will be excluded from the study: patients with major head trauma as the acute precipitant of the seizure; cardiac arrest; or a hear rate less than 40 beats per minute (since these conditions require alternative treatments).
Patients who have priorly received treatment for their present episode of status epilepticus using antiseizure medications other than benzodiazepines or who have had their trachea intubated will be excluded from the study.
Patients with known allergy or contraindications to fosphenytoin, also the patients with comorbid conditions like known inborn metabolic disorder, cardiac arrhythmias, or severe renal impairment, will be excluded from the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary efficacy:
Proportion of patients with clinical seizure cessation at 30-minutes after administration of study-drugs, and electrographic seizure cessation at 2-hours after administration of loading-dose of the study-drugs. Improvement in the responsiveness at 60-minutes after the start of trial-drug, and no requirement of additional ASM.
Primary safety:
Composite of life-threatening-hypotension or cardiac-arrhythmia within 60-minutes after the start of study-drug-infusion. 		 Clinical seizure cessation at 30-minutes after administration of the study-drugs. Electrographic seizure cessation 2-hours after administration of loading dose of the study-drugs.
Improvement in the responsiveness at 60-minutes after the start of study-drugs.
Composite of life-threatening-hypotension or cardiac-arrhythmia within 60-minutes after the start of study-drug-infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary efficacy outcome measure is the time required for seizure cessation or termination from the start of the study drug from either arm; admission to the intensive-care unit (ICU); length of ICU hospitalisation and overall hospital stay in days. The time interval between the start of the trial drug and cessation of the clinically apparent seizures will be referred as ‘time to seizure termination’.
Additional safety measures include endotracheal or tracheostomy intubation within 60 minutes, acute seizure recurrence between 60 minute to 12 hours, and acute anaphylaxis after the start of study drug infusion through IV or after the administration of IM injection. 		 Acute seizure recurrence between 60 minute to 12 hours. 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary research question?

Whether the efficacy, safety, and tolerability aspects of intramuscular fosphenytoin support its use as an adjunct abortive therapy in pediatric SE management when intravenous access is delayed or difficult, especially in primary-care or secondary-care settings?

 

Research hypothesis:

As an abortive therapy for pediatric SE, intramuscular fosphenytoin is non-inferior to intravenous fosphenytoin in achieving clinical and electrographic seizure cessation with better efficacy, safety, and tolerability profile.


What this study adds? How this study might affect research, practice, or policy:

·This study will compare efficacy, safety, and tolerability of intermuscular fosphenytoin in comparison with intravenous fosphenytoin in pediatric patients who will be admitting to emergency-triage due to out-hospital SE or to pediatric intensive-care due to in-hospital SE. It will provide ‘Class-I evidence’ about the choice of route of administration of fosphenytoin, especially when intravenous access is difficult or delayed.
·If the study demonstrates non-inferiority of intramuscular fosphenytoin when compared with intravenous fosphenytoin among pediatric patients with status epilepticus, it may change the clinical practice and potentially improve ease of treatment and reduce the cost of therapy.
 
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