Trial · NCT05610085
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
NCT05610085, Phase 2, Recruiting, University of California, San Diego
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures. Trials, record NCT05610085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05610085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
- NCT number
- NCT05610085
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 133 participants, estimated
- Lead sponsor
- University of California, San Diego
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Interventions
- Levetiracetam Injection, Phenobarbital Sodium Injection
- First posted
- 2022-11-09
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is the maximum safe and tolerated dose of Levetiracetam | 4 years | A continual reassessment method will be used to determine the maximal safe and tolerated dose |
| Secondary | Levetiracetam CL | 4 years | Population pharmacokinetic parameters for LEV Clearance (CL)will be calculated |
| Secondary | Levetiracetam Vd | 4 years | Population pharmacokinetic parameters for LEV Volume of distribution (Vd) will be calculated |
| Secondary | Adverse event rates | 4 years | Rates of adverse events seen with high dose LEV treatment will be reported and compared to rates seen in PHB control arm. |
| Secondary | Long-term outcome | 8 years | Rates of adverse long-term outcome ( Death or Disability at 24 months) will be compared between treatment arms |
| Secondary | Seizure burden reduction | 4 years | Number of patients with at least 50% seizure burden reduction post treatment will be compared between randomized treatment arms |
| Secondary | Seizure freedom rates | 4 years | Number of patients who become seizure free for 24 hours post treatment will be compared between the randomized treatment groups in each stage of the study |
| Secondary | Estimate of efficacy of higher dose LEV | 4 years | Assuming no dose limiting toxicity is demonstrated and the study proceeds to completion, 50 subjects will be treated at 120mg/kg or higher dosing level. This sample size will give satisfactory power for estimating additional efficacy of higher doses. For example, if we document an additional response rate of 15%, this sample size will provide a 95% confidence interval (0.051, 0.248) around that estimate. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05610085
GET https://conductscience.org/api/trials/v1/NCT05610085/registered