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).
Brief Title
A Novel Approach to Infantile Spasms
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Infantile Spasm
Eligibility 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
* 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
Inclusion Criteria
Inclusion Criteria:
* New onset infantile spasms
* Age \> 2 months
* Age\< 2 years
* Hypsarrhythmia on video-EEG
* Normal renal function
* New onset infantile spasms
* Age \> 2 months
* Age\< 2 years
* Hypsarrhythmia on video-EEG
* Normal renal function
Gender
All
Gender Based
false
Keywords
Vigabatrin
Cosyntropin
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
2 Years
Minimum Age
2 Months
NCT Id
NCT03347526
Org Class
Other
Org Full Name
University of Colorado, Denver
Org Study Id
17-0222
Overall Status
Suspended
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
Primary Outcomes
Outcome Description
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
Outcome Measure
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
Outcome Time Frame
2 weeks
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Day 14-42
Outcome Measure
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)
Outcome Description
Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Outcome Time Frame
6 months
Outcome Measure
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Outcome Description
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.
Outcome Time Frame
18 months chronological age
Outcome Measure
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
Outcome Description
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.
Outcome Time Frame
18 months chronological age
Outcome Measure
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
2
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elissa Yozawitz
Investigator Email
eyozawit@montefiore.org
Investigator Phone
315-436-3899