Actively Recruiting

Phase Not Applicable
Age: 2Months - 14Months
All Genders
ID04302116

Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial

Led by Kullasate Sakpichaisakul · Updated on 2021-08-25

250

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Infantile spasms (IS) are seizures linked to a serious brain condition in infants, characterized by specific seizure patterns and developmental delays. Researchers are comparing two treatments to see which better stops spasms and improves brain activity: a combination of vigabatrin with high dose prednisolone versus vigabatrin alone. This trial addresses challenges in treatment availability, especially where ACTH is not accessible, like in Thailand. The study involves two groups. One group receives vigabatrin tablets in doses adjusted by weight, gradually increasing if seizures persist, continued for three months before tapering off over four weeks. The other group receives the same vigabatrin dosing plus high dose prednisolone tablets for one month, starting at 40 mg daily and increasing to 60 mg if needed, then tapered off. The treatments are given orally, and the study compares their effectiveness in stopping spasms. Participants are infants aged 2 to 14 months diagnosed with infantile spasms. Researchers will monitor seizure cessation between days 14 and 42 after treatment starts and assess brain wave activity with EEG at specific intervals. They will also track relapse, adverse reactions, and long-term epilepsy outcomes up to 18 months of age. Caregivers and medical staff will be involved throughout the study duration, which includes follow-up assessments to measure treatment responses and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Months - 14Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants receive either combination therapy with vigabatrin and high dose prednisolone for 1 month plus vigabatrin alone for 4 months, or vigabatrin alone for 4 months.

Visits occur throughout the 4-month treatment period according to treatment protocol

Follow-up

Duration - Up to 18 months after treatment ends

Participants are monitored for relapse of spasms, adverse reactions, and epilepsy outcomes up to 18 months after treatment.

Periodic visits for assessments up to 18 months post-treatment

Trial Site Locations

Total: 1 location

1

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, Thailand, 10400

Actively Recruiting

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Research Team

K

Kullasate Sakpichaisakul, MD

S

Sirorat Suwannachote, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group.

Andrew L Lux, John P Osborne

https://pubmed.ncbi.nlm.nih.gov/15509243

Practice parameter: medical treatment of infantile spasms: report of the American Academy of Neurology and the Child Neurology Society.

M T Mackay, S K Weiss, T Adams-Webber...

https://pubmed.ncbi.nlm.nih.gov/15159460

The impact of hypsarrhythmia on infantile spasms treatment response: Observational cohort study from the National Infantile Spasms Consortium.

Scott T Demarest, Renée A Shellhaas, William D Gaillard...

https://pubmed.ncbi.nlm.nih.gov/29105055