Trial · NCT01660672
Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria
NCT01660672, Phase 1, Phase 2, Completed, University of Rochester; results first posted 2014-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria. Trials, record NCT01660672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01660672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria
- NCT number
- NCT01660672
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Seizure, Epilepsy, Cerebral Malaria
- Interventions
- LEVETIRACETAM
- First posted
- 2012-08-09
- Last updated
- 2016-09-15
- Results first posted
- 2014-10-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Freedom From Seizure | 24 hours | Number of subjects free of seizure at 24 hours after initiation of treatment |
| Secondary | Toxicity Related to LVT | 1 week | Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM. |
| Secondary | Range of Plasma Concentration of LVT Across All Individuals | 72 hours | Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM. |
| Other | Number of Participants With Neurologic Sequelae at Discharge | day 7 | Number of participants with neurologic sequelae at discharge |
| Other | Number of Subjects With Retinopathy at Enrollment | Upon admission | Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic. |
| Other | Number of Subjects Exposed to Phenobarbitone Prior to Enrollment | 0 hour | Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated. |
| Other | Number of Participants Requiring AED During Admission | 7 days | Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission. |
| Other | Mean Time to Return to a BCS Score Greater Than or Equal to 4 | 7 days | Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Freedom From Seizure | 24 hours | individuals | NUMBER | |
| SECONDARY | Toxicity Related to LVT | 1 week | participants | NUMBER | |
| SECONDARY | Range of Plasma Concentration of LVT Across All Individuals | 72 hours | mcg/ml | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Neurologic Sequelae at Discharge | day 7 | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Subjects With Retinopathy at Enrollment | Upon admission | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Subjects Exposed to Phenobarbitone Prior to Enrollment | 0 hour | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Participants Requiring AED During Admission | 7 days | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Mean Time to Return to a BCS Score Greater Than or Equal to 4 | 7 days | hours | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Freedom From Seizure | LEVETIRACETAM | 7 | individuals | ||
| Toxicity Related to LVT | LEVETIRACETAM | 0 | participants | ||
| Range of Plasma Concentration of LVT Across All Individuals | LEVETIRACETAM | 35 | Full Range 20 to 50 | mcg/ml | |
| Number of Participants With Neurologic Sequelae at Discharge | LEVETIRACETAM | 2 | participants | ||
| Number of Subjects With Retinopathy at Enrollment | LEVETIRACETAM | 4 | participants | ||
| Number of Subjects Exposed to Phenobarbitone Prior to Enrollment | LEVETIRACETAM | 3 | participants | ||
| Number of Participants Requiring AED During Admission | LEVETIRACETAM | 6 | participants | ||
| Mean Time to Return to a BCS Score Greater Than or Equal to 4 | LEVETIRACETAM | 35.3 | Full Range 7 to 78 | hours |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LEVETIRACETAM | 7 | |
| Overall Study | COMPLETED | LEVETIRACETAM | 7 | |
| Overall Study | NOT COMPLETED | LEVETIRACETAM | 0 |
Source ClinicalTrials.gov
Adverse events3
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 | Electrolyte | Blood and lymphatic system disorders | LEVETIRACETAM | 2 | 7 | 3 |
| other | GI Symptoms | Gastrointestinal disorders | LEVETIRACETAM | 6 | 7 | 6 |
| other | Hematologic abnormality | Blood and lymphatic system disorders | LEVETIRACETAM | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LEVETIRACETAM | ||
| Total, other adverse events | LEVETIRACETAM | 6 | 7 |
| Total, serious adverse events | LEVETIRACETAM | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31672143 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01NS074409 | A Dose-Escalation, Safety and Feasibility Study of Enteral Levetiracetam for Seizure Control in Pediatric Cerebral Malaria | BIRBECK, GRETCHEN L. | UNIVERSITY OF ROCHESTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2012 to 2014 |
Source NIH RePORTER
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/NCT01660672
GET https://conductscience.org/api/trials/v1/NCT01660672/registered