A Novel Approach to Infantile Spasms
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 2 |
| Updated: | 8/19/2018 |
| Start Date: | April 19, 2018 |
| End Date: | August 2021 |
A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
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).
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:
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.
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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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