Combining vigabatrin and high dose prednisolone for treating infantile spasms
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial
NA · Queen Sirikit National Institute of Child Health · NCT04302116
This study is testing if combining vigabatrin with high doses of prednisolone can help infants with infantile spasms feel better compared to using vigabatrin alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 2 Months to 14 Months |
| Sex | All |
| Sponsor | Queen Sirikit National Institute of Child Health (other gov) |
| Locations | 1 site (Ratchathewi, Bangkok) |
| Trial ID | NCT04302116 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a combination therapy of vigabatrin and high dose prednisolone against vigabatrin alone in treating infantile spasms, a severe form of epilepsy in infants. The trial will enroll Thai infants aged 2 to 14 months who have been clinically diagnosed with infantile spasms. The study will assess both the cessation of spasms and the electrographic response to treatment, which are critical for optimal neurodevelopmental outcomes. Given the challenges of ACTH availability and cost in developing countries, this research seeks to provide a viable alternative treatment option.
Who should consider this trial
Good fit: Ideal candidates for this study are Thai infants aged 2 to 14 months diagnosed with infantile spasms.
Not a fit: Patients with previous treatment using vigabatrin or corticosteroids, or those with specific contraindications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could improve treatment outcomes for infants suffering from infantile spasms, leading to better neurodevelopmental results.
How similar studies have performed: Other studies have indicated that combined steroid treatments with vigabatrin are more effective than steroid treatment alone, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ratchathewi, Bangkok
- Queen Sirikit National Institute of Child Health — Ratchathewi, Bangkok, Thailand (RECRUITING)
Study contacts
- Principal investigator: Kullasate Sakpichaisakul, MD — Queen Sirikit National Institute of Child Health
- Study coordinator: Kullasate Sakpichaisakul, MD
- Email: kullasate.s@rsu.ac.th
- Phone: 66-2-354-8333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infantile Spasm, West Syndrome, Vigabatrin, Prednisolone, Treatment