Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
394 participants
INTERVENTIONAL
2018-04-19
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Injectable + oral solution
Cosyntropin Injectable Suspension, 1 mg/mL
Cosyntropin Injectable Suspension, 1 mg/mL
Injectable
Vigabatrin
Vigabatrin
oral
Interventions
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Cosyntropin Injectable Suspension, 1 mg/mL
Injectable
Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Injectable + oral solution
Vigabatrin
oral
Eligibility Criteria
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Inclusion Criteria
* Age \> 2 months
* Age\< 2 years
* Hypsarrhythmia on video-EEG
* Normal renal function
Exclusion Criteria
* 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
2 Months
2 Years
ALL
No
Sponsors
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Pediatric Epilepsy Research Foundation
UNKNOWN
West Therapuetics, Inc
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Kelly G. Knupp, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Countries
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Other Identifiers
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17-0222
Identifier Type: -
Identifier Source: org_study_id
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