Summary

for people ages 2 months to 2 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Nilika Singhal

Description

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).

Official Title

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

Details

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.

Keywords

Infantile Spasm Vigabatrin Cosyntropin Spasm Spasms, Infantile Cosyntropin Injectable Suspension, 1 mg/mL Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin

Eligibility

You can join if…

Open to people ages 2 months to 2 years

  • New onset infantile spasms
  • Age > 2 months
  • Age< 2 years
  • Hypsarrhythmia on video-EEG
  • Normal renal function

You CAN'T join if...

  • 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

  • UCSF Medical Center
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Lead Scientist

  • Nilika Singhal
    Associate Professor, Neurology. Authored (or co-authored) 11 research publications

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of Colorado, Denver
ID
NCT03347526
Phase
Phase 3
Study Type
Interventional
Last Updated