A Novel Approach to Infantile Spasms
- Conditions
- Infantile Spasm
- Interventions
- Registration Number
- NCT03347526
- Lead Sponsor
- University of Colorado, Denver
- 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 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 394
- New onset infantile spasms
- Age > 2 months
- Age< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cosyntropin Injectable Suspension, 1 mg/mL Cosyntropin Injectable Suspension, 1 mg/mL - Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin - Vigabatrin Vigabatrin -
- Primary Outcome Measures
Name Time Method A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b). 2 weeks a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
- Secondary Outcome Measures
Name Time Method 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) Day 14-42 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.
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy). 18 months chronological age 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.
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months. 6 months Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Trial Locations
- Locations (14)
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Healthcare of Atlanta at Scottish Rite
🇺🇸Atlanta, Georgia, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States