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Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria (LVT1)

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ClinicalTrials.gov Identifier: NCT01660672
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : October 17, 2014
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gretchen Birbeck, University of Rochester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Seizure
Epilepsy
Cerebral Malaria
Intervention Drug: LEVETIRACETAM
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 7 participants
40.8
(27 to 71)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
7
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malawi Number Analyzed 7 participants
7
1.Primary Outcome
Title Freedom From Seizure
Hide Description Number of subjects free of seizure at 24 hours after initiation of treatment
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: individuals
7
2.Secondary Outcome
Title Toxicity Related to LVT
Hide Description 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.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Range of Plasma Concentration of LVT Across All Individuals
Hide Description 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.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose.

Overall Number of Participants Analyzed 7
Mean (Full Range)
Unit of Measure: mcg/ml
35
(20 to 50)
4.Other Pre-specified Outcome
Title Number of Participants With Neurologic Sequelae at Discharge
Hide Description Number of participants with neurologic sequelae at discharge
Time Frame day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
2
5.Other Pre-specified Outcome
Title Number of Subjects With Retinopathy at Enrollment
Hide Description Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.
Time Frame Upon admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
4
6.Other Pre-specified Outcome
Title Number of Subjects Exposed to Phenobarbitone Prior to Enrollment
Hide Description Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.
Time Frame 0 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
3
7.Other Pre-specified Outcome
Title Number of Participants Requiring AED During Admission
Hide Description Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
6
8.Other Pre-specified Outcome
Title Mean Time to Return to a BCS Score Greater Than or Equal to 4
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description:

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.

Overall Number of Participants Analyzed 7
Mean (Full Range)
Unit of Measure: hours
35.3
(7 to 78)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LEVETIRACETAM
Hide Arm/Group Description

Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children.

All-Cause Mortality
LEVETIRACETAM
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEVETIRACETAM
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LEVETIRACETAM
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Blood and lymphatic system disorders   
Electrolyte   2/7 (28.57%)  3
Hematologic abnormality   1/7 (14.29%)  1
Gastrointestinal disorders   
GI Symptoms   6/7 (85.71%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gretchen Birbeck
Organization: University of Rochester Medical Center
Phone: 585-273-4265
EMail: Gretchen_Birbeck@URMC.Rochester.edu
Layout table for additonal information
Responsible Party: Gretchen Birbeck, University of Rochester
ClinicalTrials.gov Identifier: NCT01660672     History of Changes
Other Study ID Numbers: LVT1R01NS074409
1R01NS074409-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2012
First Posted: August 9, 2012
Results First Submitted: August 11, 2014
Results First Posted: October 17, 2014
Last Update Posted: September 15, 2016