Trial · NCT01982812

A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM

NCT01982812, Phase 2, Completed, University of Rochester; results first posted 2016-07-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM. Trials, record NCT01982812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01982812

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
NCT number: NCT01982812
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: University of Rochester
Conditions: Seizure, Epilepsy, Cerebral Malaria
Interventions: Oral Levetiracetam, Standard AED
First posted: 2013-11-13
Last updated: 2016-07-29
Results first posted: 2016-07-29

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Minutes With Seizure on EEG	72 hours	Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.
Secondary	Required Additional AED	7 days	Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)
Secondary	Mean Time From Admission to BCS >/= 4	7 days	The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis. The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement 1 - Watches or follows 0 - Fails to watch or follow Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks 1 - Moan or abnormal cry with pain 0 - No vocal response to pain
Secondary	Sequelae	7 days	Neurologic outcome in 3 categories-- 1. Neurologically intact at discharge 2. Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge 3. Died during admission, never discharged

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Minutes With Seizure on EEG	72 hours		minutes with seizure	MEAN
SECONDARY	Required Additional AED	7 days		Participants requiring additional AEDs	NUMBER
SECONDARY	Mean Time From Admission to BCS >/= 4	7 days	Comparing mean time to coma resolution in hours among survivors	hours of coma from admission	MEAN
SECONDARY	Sequelae	7 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Minutes With Seizure on EEG	Oral Levetiracetam		165.2	Standard Deviation 265.9	minutes with seizure
Minutes With Seizure on EEG	Comparison Group		464.8	Standard Deviation 639.3	minutes with seizure
Required Additional AED	Oral Levetiracetam		18		Participants requiring additional AEDs
Required Additional AED	Comparison Group		18		Participants requiring additional AEDs
Mean Time From Admission to BCS >/= 4	Oral Levetiracetam		35.4	Standard Deviation 29.0	hours of coma from admission
Mean Time From Admission to BCS >/= 4	Comparison Group		34.6	Standard Deviation 27.8	hours of coma from admission
Sequelae	Oral Levetiracetam	Neurologically intact at discharge	19		participants
Sequelae	Comparison Group	Neurologically intact at discharge	14		participants
Sequelae	Oral Levetiracetam	Neurologic sequelae at discharge	3		participants
Sequelae	Comparison Group	Neurologic sequelae at discharge	2		participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Levetiracetam	23
Overall Study	STARTED	Comparison Group	21
Overall Study	COMPLETED	Oral Levetiracetam	22
Overall Study	COMPLETED	Comparison Group	11
Overall Study	NOT COMPLETED	Oral Levetiracetam	1
Overall Study	NOT COMPLETED	Comparison Group	10

Source ClinicalTrials.gov

Adverse events48

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	myoclonus	Nervous system disorders	Oral Levetiracetam	1	23	1
other	myoclonus	Nervous system disorders	Comparison Group	0	21	0
other	Anemia with persistent low retics	Blood and lymphatic system disorders	Oral Levetiracetam	0	23	0
other	Anemia with persistent low retics	Blood and lymphatic system disorders	Comparison Group	1	21	1
other	Increased AST	Hepatobiliary disorders	Oral Levetiracetam	5	23	7
other	Increased AST	Hepatobiliary disorders	Comparison Group	7	21	10
other	Thrombocytopenia	Blood and lymphatic system disorders	Oral Levetiracetam	2	23	2
other	Thrombocytopenia	Blood and lymphatic system disorders	Comparison Group	1	21	1
other	elevated platelet count	Blood and lymphatic system disorders	Oral Levetiracetam	1	23	1
other	elevated platelet count	Blood and lymphatic system disorders	Comparison Group	2	21	2

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Levetiracetam
Total, all-cause mortality	Comparison Group
Total, other adverse events	Oral Levetiracetam	15	23
Total, other adverse events	Comparison Group	18	21
Total, serious adverse events	Oral Levetiracetam	5	23
Total, serious adverse events	Comparison Group	8	21

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Oral Levetiracetam vs Comparison Group: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01982812

GET https://conductscience.org/api/trials/v1/NCT01982812/events?page=2

API reference For AI assistants