NCT03347526

A Novel Approach to Infantile Spasms

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 2 Months – 2 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Infantile Spasm

Interventions

Type	Name	Description
DRUG	Cosyntropin Injectable Suspension, 1 mg/mL	Injectable
DRUG	Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin	Injectable + oral solution
DRUG	Vigabatrin	oral

Timeline

• Start date: 2018-04-19
• Primary completion: 2021-06-01
• Completion: 2021-08-01
• First posted: 2017-11-20
• Last updated: 2021-05-27

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study