A Novel Approach to Infantile Spasms

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

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).

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.

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