A Novel Approach to Infantile Spasms

Status Suspended

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03347526
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Suspended
Phase	Phase 3
Start date	April 19, 2018
Completion date	August 2021

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See also
Status	Clinical Trial	Phase
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