A Novel Approach to Infantile Spasms

• Status: Suspended
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Pediatric Epilepsy Research Foundation; West Therapuetics, Inc
• Treatments: Cosyntropin; Vigabatrin

Criteria

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