Trial · NCT01720667
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
NCT01720667, Phase 1, Phase 2, Completed, Richard H. Haas; results first posted 2019-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Intravenous Levetiracetam in Neonatal Seizures. Trials, record NCT01720667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720667
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Intravenous Levetiracetam in Neonatal Seizures
- NCT number
- NCT01720667
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 280 participants, actual
- Lead sponsor
- Richard H. Haas
- Conditions
- Neonatal Seizures
- Interventions
- Intravenous levetiracetam, Intravenous phenobarbital
- First posted
- 2012-11-02
- Last updated
- 2019-08-21
- Results first posted
- 2019-08-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) | 24 hours | A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. Seizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists. |
| Secondary | Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment | 48 hours | A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. |
| Secondary | Number of Neonates With Seizure Termination at 1 Hour After Treatment | 1 hour | A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. |
| Secondary | LEV Dose Escalation Component | 24 hours | Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg. |
| Secondary | Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia | 24 hours | |
| Other | Pharmacokinetic Data | 48 hours | To obtain additional pharmacokinetic data "Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax)" of intravenous levetiracetam to confirm findings from our previous pharmacokinetic study. |
| Other | Feasibility of Continuous Internet EEG Monitoring | Subject study duration | Feasibility of centralized remote access to continuous video EEG monitoring in the NICU via the internet |
| Other | Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm | 48 Hours | A novel neonatal seizure detection algorithm will be compared to the gold standard of two encephalographers reading 48 hours of neonatal video EEG in the measurement of seizure burden. |
| Other | Gather Safety Information on IV Levetiracetam | 5 days | Safety information to be collected includes daily recording of any adverse events during the 5 day treatment protocol. Complete Blood Count and Comprehensive Chemistry panels after 48 hours of treatment collected. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) | 24 hours | Treated participants with available primary outcome measure- EEG to 24 hours confirming seizure cessation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment | 48 hours | Participants with evaluable data with 48 hours of seizure monitoring | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Neonates With Seizure Termination at 1 Hour After Treatment | 1 hour | Includes 1 participant in each arm who did not have data available for the primary end point at 24 hours | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | LEV Dose Escalation Component | 24 hours | Babies who received any treatment of either phenobarbital or levetiracetam within the modified intent to treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia | 24 hours | HIE participants with hypothermia treatment | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Pharmacokinetic Data | 48 hours | |||
| OTHER_PRE_SPECIFIED | Feasibility of Continuous Internet EEG Monitoring | Subject study duration | |||
| OTHER_PRE_SPECIFIED | Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm | 48 Hours | |||
| OTHER_PRE_SPECIFIED | Gather Safety Information on IV Levetiracetam | 5 days | |||
| POST_HOC | Imputation Sensitivity Analysis | 48 hours |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) | Intravenous Levetiracetam | 15 | Participants | ||
| Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) | Intravenous Phenobarbital | 24 | Participants | ||
| Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment | Intravenous Levetiracetam | 8 | Participants | ||
| Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment | Intravenous Phenobarbital | 18 | Participants | ||
| Number of Neonates With Seizure Termination at 1 Hour After Treatment | Intravenous Levetiracetam | 26 | Participants | ||
| Number of Neonates With Seizure Termination at 1 Hour After Treatment | Intravenous Phenobarbital | 28 | Participants | ||
| LEV Dose Escalation Component | Intravenous Levetiracetam | 4 | Participants | ||
| LEV Dose Escalation Component | Intravenous Phenobarbital | 3 | Participants | ||
| Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia | Intravenous Levetiracetam | 6 | Participants | ||
| Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia | Intravenous Phenobarbital | 9 | Participants |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravenous Levetiracetam | 64 | |
| Overall Study | STARTED | Intravenous Phenobarbital | 42 | |
| Overall Study | Recieved Second Infusion of Same Drug | Intravenous Levetiracetam | 50 | |
| Overall Study | Recieved Second Infusion of Same Drug | Intravenous Phenobarbital | 20 | |
| Overall Study | Recieved Alternate Intervention | Intravenous Levetiracetam | 45 | |
| Overall Study | Recieved Alternate Intervention | Intravenous Phenobarbital | 10 | |
| Overall Study | Received 2nd Infusion of Alternate Drug | Intravenous Levetiracetam | 27 | |
| Overall Study | Received 2nd Infusion of Alternate Drug | Intravenous Phenobarbital | 6 | |
| Overall Study | Modified ITT | Intravenous Levetiracetam | 53 | |
| Overall Study | Modified ITT | Intravenous Phenobarbital | 30 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | Intravenous Phenobarbital | 7 | 42 | |
| other | Hypotension | Vascular disorders | Intravenous Levetiracetam | 3 | 64 | |
| other | Heart Rate Abnormailty | Cardiac disorders | Intravenous Phenobarbital | 1 | 42 | |
| other | Heart Rate Abnormailty | Cardiac disorders | Intravenous Levetiracetam | 3 | 64 | |
| other | Respiratory Abnormality | Respiratory, thoracic and mediastinal disorders | Intravenous Phenobarbital | 12 | 42 | |
| other | Respiratory Abnormality | Respiratory, thoracic and mediastinal disorders | Intravenous Levetiracetam | 8 | 64 | |
| other | Sedation | Nervous system disorders | Intravenous Phenobarbital | 8 | 42 | |
| other | Sedation | Nervous system disorders | Intravenous Levetiracetam | 7 | 64 | |
| other | Poor Feeding | Gastrointestinal disorders | Intravenous Phenobarbital | 7 | 42 | |
| other | Poor Feeding | Gastrointestinal disorders | Intravenous Levetiracetam | 6 | 64 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous Phenobarbital | 1 | 42 |
| Total, all-cause mortality | Intravenous Levetiracetam | 2 | 64 |
| Total, other adverse events | Intravenous Phenobarbital | 13 | 42 |
| Total, other adverse events | Intravenous Levetiracetam | 12 | 64 |
| Total, serious adverse events | Intravenous Phenobarbital | 5 | 42 |
| Total, serious adverse events | Intravenous Levetiracetam | 1 | 64 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD004147 | Phase 2 Study of Levetiracetam for Neonatal Seizures | HAAS, RICHARD H | UNIVERSITY OF CALIFORNIA, SAN DIEGO | FOOD AND DRUG ADMINISTRATION | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Intravenous Levetiracetam vs Intravenous Phenobarbital: Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia | Trial comparisons |
| Intravenous Levetiracetam vs Intravenous Phenobarbital: Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment | Trial comparisons |
| Intravenous Levetiracetam vs Intravenous Phenobarbital: Number of Neonates With Seizure Termination at 1 Hour After Treatment | Trial comparisons |
| Intravenous Levetiracetam vs Intravenous Phenobarbital: Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg) | Trial comparisons |
| Intravenous Phenobarbital vs Intravenous Levetiracetam: deaths from any cause | Trial comparisons |
| Intravenous Levetiracetam vs Intravenous Phenobarbital: LEV Dose Escalation Component | Trial comparisons |
| Intravenous Phenobarbital vs Intravenous Levetiracetam: serious adverse events | Trial comparisons |
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.
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