Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms (PREDVGB)
Infantile Spasms
About this trial
This is an interventional treatment trial for Infantile Spasms focused on measuring Vigabatrin, Prednisolone
Eligibility Criteria
Inclusion Criteria: Inclusion criteria:
- Age 2-24 months
- Clinical spasms
- Initial EEG with hypsarrhythmia or modified hypsarrhythmia
The inclusion criteria do not quantify the initial severity or frequency of infantile spasms. Infantile spasms is a unique epileptic disorder characterized by clusters of brief infantile spasms, where each one lasts a few seconds and cluster may last minutes. The diagnosis of infantile spasms and response to medication depends on the presence or absence of these events and the frequency of infantile spasms has not been used to determine medication efficacy in previous studies. A seizure diary will be used to quantify the seizure burden, however efficacy will depend on complete resolution of clinical spasms and resolution of hypsarrhythmia on EEG -
Exclusion Criteria:
- Age <2months or older than 24 months
- Tuberous sclerosis (if known at the time of enrolment)
- Previous treatment (within 28 days) with VGB or hormonal treatments
- Contraindications to hormonal therapy: This includes untreated systemic fungal infections, known hypersensitivity to prednisolone or other corticosteroids, or to any of the non-medicinal ingredients present in the solution. Active or latent tuberculosis, ocular herpes simplex, hypothyroidism, hepatic cirrhosis, nonspecific ulcerative colitis, abscess or other pyogenic infection, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, cardiac disease, thromboembolic disorders and diabetes mellitus. All patients with cardiac risk factors will receive an electrocardiogram (ECG), chest xray (CXR) and cardiology referral if indicated. Patients diagnosed with cardiac disorders will be excluded from the study since high dose steroids may exacerbate arrhythmias.
- Inability of parents or guardians to give consent
- Enrolment in a concurrent treatment trial that might affect outcome measures of this trial -
Sites / Locations
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Prednisolone
Vigabatrin
Single center, prospective, observational, open trial using high-dose oral prednisolone as first-line treatment for newly diagnosed Infantile Spasms (non-Tuberous Sclerosis)
Retrospective controls composed of our cohort of non-Tuberous Sclerosis Infantile Spasms patients from January 2010- September 2013 who received Vigabatrin as first-line treatment.