Status:
WITHDRAWN
Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Infantile Spasms
Eligibility:
All Genders
2-24 years
Phase:
PHASE3
Brief Summary
Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy Neurology/ Child Neurology Society practice parameter update on the medical treatment of infantile spasms c...
Detailed Description
Background and Rationale for the study: Infantile spasms (IS) is a rare, catastrophic age-specific epilepsy syndrome with onset within the first 12 months of life. The disorder is characterized clini...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02299115
Start Date
September 5 2017
End Date
March 6 2019
Last Update
November 14 2019
Active Locations (1)
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1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8