A Novel Approach to Infantile Spasms

Overview

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).

Full Title of Study: “A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

Detailed Description

This is a prospective randomized trial comparing 3 treatment arms: 1. Cosyntropin Injectable Suspension, 1 mg/mL 2. Vigabatrin 3. 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.

Interventions

  • Drug: Cosyntropin Injectable Suspension, 1 mg/mL
    • Injectable
  • Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
    • Injectable + oral solution
  • Drug: Vigabatrin
    • oral

Arms, Groups and Cohorts

  • Experimental: Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
  • Experimental: Cosyntropin Injectable Suspension, 1 mg/mL
  • Active Comparator: Vigabatrin

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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)
    • Time Frame: Day 14-42
    • 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.
  • A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
    • Time Frame: 6 months
    • Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
  • Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
    • Time Frame: 18 months chronological age
    • 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.
  • Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
    • Time Frame: 18 months chronological age
    • 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.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 2 Months

    Maximum Age: 2 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Colorado, Denver
    • Collaborator
      • Pediatric Epilepsy Research Foundation
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Kelly G. Knupp, MD, Principal Investigator, University of Colorado – Anschutz Medical Campus

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