A Novel Approach to Infantile Spasms

Study Overview
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Brief Summary
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This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).

Detailed Description
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This is a prospective randomized trial comparing 3 treatment arms: Cosyntropin Injectable Suspension, 1 mg/mL Vigabatrin Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures. The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.

Official Title
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A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy

Conditions
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Infantile Spasm

Intervention / Treatment
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* Drug: Cosyntropin Injectable Suspension, 1 mg/mL
* Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
* Drug: Vigabatrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New onset infantile spasms Age > 2 months Age< 2 years Hypsarrhythmia on video-EEG Normal renal function Exclusion Criteria: Prior treatment given for infantile spasms Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy Absence of hypsarrhythmia Inability for the parent or caregiver to provide consent Inability for the parent or caregiver to complete seizure diary Diagnosis of: scleroderma, osteoporosis, recent systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin<br> | Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin<br>* Injectable + oral solution<br>|
| Experimental: Cosyntropin Injectable Suspension, 1 mg/mL<br> | Drug: Cosyntropin Injectable Suspension, 1 mg/mL<br>* Injectable<br>|
| Active Comparator: Vigabatrin<br> | Drug: Vigabatrin<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b). | a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b) | a) Resolution of clinical spasms for 48 hours at 2 weeks sustained until day 42, and b) Resolution of hypsarrhythmia via video EEG at 2 weeks. | Day 14-42 | 
| A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months. | Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment. | 6 months | 
| Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy). | A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Adaptive Behavior Assessment System (ABAS III) at 18 months chronological age. | 18 months chronological age | 
| Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy). | A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Vineland II at 18 months chronological age. | 18 months chronological age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vigabatrin, Cosyntropin