A Novel Approach to Infantile Spasms

University of Colorado, Denver394 enrolled

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

394

Conditions

Infantile Spasm

Interventions

Cosyntropin Injectable Suspension, 1 mg/mLDRUG

Injectable

Cosyntropin Injectable Suspension 1 MG/ML + vigabatrinDRUG

Injectable + oral solution

VigabatrinDRUG

oral

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (14)

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Outcomes

Primary Outcomes

A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).

a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.

Time frame: 2 weeks

Secondary Outcomes

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)

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.

Time frame: Day 14-42

A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.

Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.

Time frame: 6 months

Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).

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.

Time frame: 18 months chronological age

Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).

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.

Time frame: 18 months chronological age

Data from ClinicalTrials.gov

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