Study Stopped
Study on enrollment hold as a precaution per the pharmaceutical company.
A Novel Approach to Infantile Spasms
1 other identifier
interventional
394
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
April 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMay 27, 2021
May 1, 2021
3.1 years
November 15, 2017
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
2 weeks
Secondary Outcomes (4)
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 comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
6 months
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
18 months chronological age
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
18 months chronological age
Study Arms (3)
Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
EXPERIMENTALCosyntropin Injectable Suspension, 1 mg/mL
EXPERIMENTALVigabatrin
ACTIVE COMPARATORInterventions
Injectable + oral solution
Eligibility Criteria
You may qualify if:
- New onset infantile spasms
- Age \> 2 months
- Age\< 2 years
- Hypsarrhythmia on video-EEG
- Normal renal function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Pediatric Epilepsy Research Foundationcollaborator
- West Therapuetics, Inccollaborator
Study Sites (14)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UCSF Medical Center
San Francisco, California, 94158, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly G. Knupp, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Blinded outcome measure
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2017
First Posted
November 20, 2017
Study Start
April 19, 2018
Primary Completion
June 1, 2021
Study Completion
August 1, 2021
Last Updated
May 27, 2021
Record last verified: 2021-05