Trial | NCT03347526  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    394
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:

Cosyntropin Injectable Suspension, 1 mg/mL
Vigabatrin
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 Started
Apr 19
2018
Primary Completion
Jun 30
2021
Anticipated
Study Completion
Aug 31
2021
Anticipated
Last Update
May 27
2021

Drug Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin [tetracosactide, vigabatrin (sabril)]

Injectable + oral solution

Drug Vigabatrin

oral

Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin Experimental

Cosyntropin Injectable Suspension, 1 mg/mL Experimental

Vigabatrin Active Comparator

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
No Results Posted