Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-14
SponsorKullasate Sakpichaisakul
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Combination therapy with vigabatrin and prednisolone
DrugHigh dose prednisolone (40 - 60 mg/day) for 1 month combined with vigabatrin treatment (50-150 mg/kg/day) twice daily for 4 months
Vigabatrin Tablets
DrugVigabatrin (50-150 mg/kg/day) twice daily for 4 months
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Combination therapy with vigabatrin and prednisoloneExperimental treatment 1 intervention
Group B: Vigabatrin aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cessation of spasms
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 outcomes
1
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.
Time frame
Assessed during Day 14 and Day 43 after treatment.2
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.
Time frame
Between Day 14 and Day 21.3
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.
Time frame
Between Day 42 and Day 49.4
The time taken to absence of spasms
Duration for clinical cessation of spasms after initiation treatment
Time frame
Day 1 to Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kullasate Sakpichaisakul
Lead sponsor
Queen Sirikit National Institute of Child Health
Sponsor institution
Source ClinicalTrials.gov