Clinical trialNCT03347526SuspendedPhase 3Interventional

A Novel Approach to Infantile Spasms

SponsorUniversity of Colorado, DenverEnrollment394Infantile Spasm

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Kelly G. Knupp, MD
University of Colorado, Denver
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cosyntropin Injectable Suspension 1 MG/ML + vigabatrinCosyntropin Injectable Suspension, 1 mg/mLVigabatrin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Apr 2018
Primary completion: 30 Jun 2021
Completion: 31 Aug 2021
Last update posted: 27 May 2021
Registered enrollment: 394
Registry id: NCT03347526

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.