Status:
SUSPENDED
A Novel Approach to Infantile Spasms
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Pediatric Epilepsy Research Foundation
West Therapuetics, Inc
Conditions:
Infantile Spasm
Eligibility:
All Genders
2-2 years
Phase:
PHASE3
Brief 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 Cosyn...
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 Suspensio...
Eligibility Criteria
Inclusion
- New onset infantile spasms
- Age \> 2 months
- Age\< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT03347526
Start Date
April 19 2018
End Date
August 1 2021
Last Update
May 27 2021
Active Locations (14)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
UCSF Medical Center
San Francisco, California, United States, 94158
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010