A Novel Approach to Infantile Spasms
Public ClinicalTrials.gov record NCT03347526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03347526
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 394 participants
Conditions and interventions
Conditions
Interventions
- Cosyntropin Injectable Suspension, 1 mg/mL Drug
- Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin Drug
- Vigabatrin Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Months to 2 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 19, 2018 (Actual)
- Primary completion
- Jun 2021 (Estimated)
- Completion
- Aug 2021 (Estimated)
- Last update posted
- May 27, 2021
2018 – 2021
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| UCSF Medical Center | San Francisco | California | 94158 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Atrium Health | Charlotte | North Carolina | 28204 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03347526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03347526 live on ClinicalTrials.gov.