Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02299115
• Date of registration: 18/11/2014
• Prospective Registration: Yes
• Primary sponsor: The Hospital for Sick Children
• Public title: Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms PREDVGB
• Scientific title: Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms
• Date of first enrolment: September 5, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02299115
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Carter Snead, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion criteria

Inclusion Criteria: Inclusion criteria:

1. Age 2-24 months

2. Clinical spasms

3. 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:

1. Age <2months or older than 24 months

2. Tuberous sclerosis (if known at the time of enrolment)

3. Previous treatment (within 28 days) with VGB or hormonal treatments

4. 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.

5. Inability of parents or guardians to give consent

6. Enrolment in a concurrent treatment trial that might affect outcome measures of this
trial -



Age minimum: 2 Months
Age maximum: 24 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infantile Spasms

Intervention(s)

Drug: Vigabatrin

Drug: Prednisolone

Primary Outcome(s)

Resolution of Infantile spasms and Hypsarrhythmia [Time Frame: 14 days]

Secondary Outcome(s)

Time to relapse [Time Frame: 6 months]

Seizure outcome at final follow up (presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit) [Time Frame: 6 months]

Clinical or EEG relapse of Infantile Spasms [Time Frame: 6 months]

Time to cessation of Infantile spasms [Time Frame: 14 days]

Secondary ID(s)

1000045463

Source(s) of Monetary Support

Please refer to primary and secondary sponsors