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Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

Primary Purpose

Infantile Spasm, West Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Combination therapy with vigabatrin and prednisolone
Vigabatrin Tablets
Sponsored by
Kullasate Sakpichaisakul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Spasm focused on measuring Infantile Spasm, Vigabatrin, Prednisolone, Treatment, West Syndrome

Eligibility Criteria

2 Months - 14 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age at 2-14 months at date of enrollment
  • Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist
  • Thai nationality

Exclusion Criteria:

  • Previous treatment (within the last 28 days) with vigabatrin or corticosteroid
  • Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy
  • Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys
  • A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc.
  • Thai language ability of the parents or guardians is that they may not understand what is being requested of them.
  • Predictable lack of availability of follow up

Sites / Locations

  • Queen Sirikit National Institute of Child HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination therapy with vigabatrin and prednisolone

Vigabatrin alone

Arm Description

Vigabatrin (tablet of 500 mg) dose based on weight divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks. Prednisolone (tablet of 5 mg), 40 mg of prednisolone (10 mg oral 4 times a day) for 14 days. Prednisolone will be increased to 60 mg/day (20 mg oral 3 times a day) if seizures still occur at Day 7 or recur within Day 8 - 14. Then, prednisolone will be reduced every 5 day until completely off within 1 month. Total prednisolone duration is 1 month.

Vigabatrin (500 mg/tab) dose will be calculated on weight basis divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.

Outcomes

Primary Outcome Measures

Cessation of spasms
Defined as no witnessed spasms (either clusters or single spasms) from Day 14 to Day 42 inclusive.

Secondary Outcome Measures

Electrographic response
Disappearance of hypsarrhythmia defined by Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system < 2 at Day 14 and Day 43 after treatment.
Electroclinical response
the cessation of spasms with the addition of absence of hypsarrhythmia (BASED score < 2) on the Day 14 EEG. Valid Day 14 EEGs will be undertaken between Day 14 and Day 21 inclusive.
Extended electroclinical response
Electroclinical response with the addition of absence of hypsarrhythmia (BASED score < 2) on the Day 42 EEG. Valid Day 42 EEGs will be undertaken between Day 42 and Day 49 inclusive.
The time taken to absence of spasms
Duration for clinical cessation of spasms after initiation treatment
Relapse of spasms
Defined when a cluster of more than one spasm in reported after Day 42. No EEG is required.
Adverse reactions
Each adverse event will be evaluated by the principal investigator to determine whether in their view it is an adverse reaction. If considered an adverse reaction, it will be reported by using the standard classification.
Epilepsy outcome at age 18 months
Epilepsy status and antiepileptic drugs (AEDs) will be recorded by using the following categories: 1) Infantile spasms (clusters of spasms), 2) Any other epileptic seizure including febrile seizures, and 3) Names of any preventive AEDs prescribed

Full Information

First Posted
March 5, 2020
Last Updated
August 24, 2021
Sponsor
Kullasate Sakpichaisakul
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1. Study Identification

Unique Protocol Identification Number
NCT04302116
Brief Title
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Official Title
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kullasate Sakpichaisakul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.
Detailed Description
Infantile spasms are recognized as epileptic encephalopathy which include the hypsarrhythmia or variants electroencephalographic (EEG) features and psychomotor regression. Various underlying conditions are associated with the infantile spasm included cerebral malformation, hypoxic ischemic encephalopathy, genetic disorders (Down syndrome), tuberous sclerosis complex (TSC), etc. Although vigabatrin has the evidence to use as the first line treatment for infantile spasm related with TSC. Adrenocorticotrophic hormone (ACTH), or high dose prednisolone, or vigabatrin are the first line treatment of IS in non-TSC. The effectiveness of ACTH versus high dose prednisolone question have not yet definitely answered. Furthermore, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first option of therapy recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Questions about the clinical cessation of IS and electrographic remission by combination treatment with vigabatrin and high dose prednisolone compare to vigabatrin alone have not fully elucidated. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Spasm, West Syndrome
Keywords
Infantile Spasm, Vigabatrin, Prednisolone, Treatment, West Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pragmatic parallel group randomised trial comparing vigabatrin with high dose prednisolone to vigabatrin treatment alone in the treatment of infantile spasm.
Masking
InvestigatorOutcomes Assessor
Masking Description
Each patient will visit the clinic at Day 8, 14, 43, and 3 months by outcome assessor who is blinded for treatment to determine seizure frequency and adverse events. Those patients will be seen and under taking care of primary neurologists and pharmacists who are not blinded to treatment at the same visit as a standard clinical practice and check with compliance and adjust vigabatrin or prednisolone following each treatment allocated (if needed). Family or caregivers will not be blinded to treatment. EEG will be scored using BASED scores at Day 0 (before treatment), 14, and 43 to assess the resolution of hypsarrhythmia.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy with vigabatrin and prednisolone
Arm Type
Experimental
Arm Description
Vigabatrin (tablet of 500 mg) dose based on weight divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks. Prednisolone (tablet of 5 mg), 40 mg of prednisolone (10 mg oral 4 times a day) for 14 days. Prednisolone will be increased to 60 mg/day (20 mg oral 3 times a day) if seizures still occur at Day 7 or recur within Day 8 - 14. Then, prednisolone will be reduced every 5 day until completely off within 1 month. Total prednisolone duration is 1 month.
Arm Title
Vigabatrin alone
Arm Type
Active Comparator
Arm Description
Vigabatrin (500 mg/tab) dose will be calculated on weight basis divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Combination therapy with vigabatrin and prednisolone
Other Intervention Name(s)
Sabril with prednisolone
Intervention Description
High dose prednisolone (40 - 60 mg/day) for 1 month combined with vigabatrin treatment (50-150 mg/kg/day) twice daily for 4 months
Intervention Type
Drug
Intervention Name(s)
Vigabatrin Tablets
Other Intervention Name(s)
Sabril
Intervention Description
Vigabatrin (50-150 mg/kg/day) twice daily for 4 months
Primary Outcome Measure Information:
Title
Cessation of spasms
Description
Defined as no witnessed spasms (either clusters or single spasms) from Day 14 to Day 42 inclusive.
Time Frame
Assessed during Day 14 to Day 42 after treatment.
Secondary Outcome Measure Information:
Title
Electrographic response
Description
Disappearance of hypsarrhythmia defined by Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system < 2 at Day 14 and Day 43 after treatment.
Time Frame
Assessed during Day 14 and Day 43 after treatment.
Title
Electroclinical response
Description
the cessation of spasms with the addition of absence of hypsarrhythmia (BASED score < 2) on the Day 14 EEG. Valid Day 14 EEGs will be undertaken between Day 14 and Day 21 inclusive.
Time Frame
Between Day 14 and Day 21.
Title
Extended electroclinical response
Description
Electroclinical response with the addition of absence of hypsarrhythmia (BASED score < 2) on the Day 42 EEG. Valid Day 42 EEGs will be undertaken between Day 42 and Day 49 inclusive.
Time Frame
Between Day 42 and Day 49.
Title
The time taken to absence of spasms
Description
Duration for clinical cessation of spasms after initiation treatment
Time Frame
Day 1 to Day 14
Title
Relapse of spasms
Description
Defined when a cluster of more than one spasm in reported after Day 42. No EEG is required.
Time Frame
Day 42 to 3 months after treatment
Title
Adverse reactions
Description
Each adverse event will be evaluated by the principal investigator to determine whether in their view it is an adverse reaction. If considered an adverse reaction, it will be reported by using the standard classification.
Time Frame
Day 1 to Day 14, from Day 15 to Day 42, and from Day 43 to 4 months into the trial
Title
Epilepsy outcome at age 18 months
Description
Epilepsy status and antiepileptic drugs (AEDs) will be recorded by using the following categories: 1) Infantile spasms (clusters of spasms), 2) Any other epileptic seizure including febrile seizures, and 3) Names of any preventive AEDs prescribed
Time Frame
From Day 42 to age 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at 2-14 months at date of enrollment Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist Thai nationality Exclusion Criteria: Previous treatment (within the last 28 days) with vigabatrin or corticosteroid Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc. Thai language ability of the parents or guardians is that they may not understand what is being requested of them. Predictable lack of availability of follow up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kullasate Sakpichaisakul, MD
Phone
66-2-354-8333
Email
kullasate.s@rsu.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Sirorat Suwannachote, MD
Phone
66-2-354-8333
Email
sirorat.s@rsu.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kullasate Sakpichaisakul, MD
Organizational Affiliation
Queen Sirikit National Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Sirikit National Institute of Child Health
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kullasate Sakpichaisakul, MD
Email
kullasate.s@rsu.ac.th
First Name & Middle Initial & Last Name & Degree
Kantapon Trongkamolchai, MD
Email
kantapon260619870@gmail.com
First Name & Middle Initial & Last Name & Degree
Kullasate Sakpichaisakul, MD
First Name & Middle Initial & Last Name & Degree
Kantapon Trongkamolchai, MD
First Name & Middle Initial & Last Name & Degree
Somjit Sri-udomkajorn, MD
First Name & Middle Initial & Last Name & Degree
Sirorat Suwannachote, MD
First Name & Middle Initial & Last Name & Degree
Ravivan Wittawassamrankul, R Ph
First Name & Middle Initial & Last Name & Degree
Ravindra Arya, MD, DM

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available for the confidentiality.
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Links:
URL
http://thaiepilepsysociety.com/wp-content/uploads/2016/11/%E0%B9%81%E0%B8%99%E0%B8%A7%E0%B8%97%E0%B8%B2%E0%B8%87%E0%B9%80%E0%B8%A7%E0%B8%8A%E0%B8%9B%E0%B8%8F%E0%B8%B4%E0%B8%9A%E0%B8%B1%E0%B8%95%E0%B8%B4%E0%B9%82%E0%B8%A3%E0%B8%84%E0%B8%A5%E0%B8%A1%E0%B8%8A%E0%B8%B1%E0%B8%81%E0%B8%AA%E0%B8%B3%E0%B8%AB%E0%B8%A3%E0%B8%B1%E0%B8%9A%E0%B9%81%E0%B8%9E%E0%B8%97%E0%B8%A2%E0%B9%8C_2015.pdf
Description
Clinical practice guidelines for epilepsy by Epilepsy Society of Thailand

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Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

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