Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
Public ClinicalTrials.gov record NCT05076838. 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
An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
Study identification
- NCT ID
- NCT05076838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 5 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
- Nov 8, 2021 (Actual)
- Primary completion
- Mar 11, 2025 (Actual)
- Completion
- Mar 11, 2025 (Actual)
- Last update posted
- Oct 20, 2026
2021 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwest Florida Clinical Research Group, LLC. | Gulf Breeze | Florida | 32561 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| AdventHealth Research Institute | Orlando | Florida | 32803 | — |
| Center for Rare Neurological Diseases | Norcross | Georgia | 30093 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Missouri Women & Children's Hospital | Columbia | Missouri | 65201 | — |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | — |
| Boston Children's Health Physicians | Hawthorne | New York | 10532 | — |
| University of Rochester | Rochester | New York | 14623 | — |
| Duke University Hospital | Durham | North Carolina | 27710 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75225 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
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 NCT05076838, 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 Oct 20, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05076838 live on ClinicalTrials.gov.