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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

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

NCT ID

NCT04302116

First Posted

March 5, 2020

Last Updated

August 24, 2021

Sponsor

Kullasate Sakpichaisakul

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Title

Vigabatrin alone

Arm Type

Active Comparator

Arm Description

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

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

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

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

kullasate.s@rsu.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Sirorat Suwannachote, MD

Phone

66-2-354-8333

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

kullasate.s@rsu.ac.th

First Name & Middle Initial & Last Name & Degree

Kantapon Trongkamolchai, MD

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

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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