A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms
Public ClinicalTrials.gov record NCT05128344. 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 Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).
Study identification
- NCT ID
- NCT05128344
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Months to 24 Months
- 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 2023 (Estimated)
- Primary completion
- Jun 2025 (Estimated)
- Completion
- Dec 2025 (Estimated)
- Last update posted
- Apr 20, 2023
2023 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Childrens Hospital Colorado | Aurora | Colorado | 80045-7106 | — |
| Miami Children's Hospital | Miami | Florida | 33155 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Arnold Palmer Hospital For Children | Orlando | Florida | 32806 | — |
| Childrens Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | — |
| Children's Brain Institute | Lexington | Massachusetts | 02420 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201-2119 | — |
| Staten Island University Hospital, North | Staten Island | New York | 10305 | — |
| Wake Forest Baptist Medical Center - PPDS | Winston-Salem | North Carolina | 27157 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75207 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05128344, 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 Apr 20, 2023 · 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 NCT05128344 live on ClinicalTrials.gov.