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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gretchen Birbeck, University of Rochester
ClinicalTrials.gov Identifier:
NCT01660672
First received: July 19, 2012
Last updated: October 16, 2014
Last verified: October 2014
Results First Received: August 11, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Seizure
Epilepsy
Cerebral Malaria
Intervention: Drug: LEVETIRACETAM

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LEVETIRACETAM

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.


Participant Flow:   Overall Study
    LEVETIRACETAM  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LEVETIRACETAM

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.


Baseline Measures
    LEVETIRACETAM  
Number of Participants  
[units: participants]
  7  
Age  
[units: months]
Mean ( Full Range )
  40.8  
  ( 27 to 71 )  
Age  
[units: participants]
 
<=18 years     7  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     4  
Male     3  
Region of Enrollment  
[units: participants]
 
Malawi     7  



  Outcome Measures
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1.  Primary:   Freedom From Seizure   [ Time Frame: 24 hours ]

2.  Secondary:   Toxicity Related to LVT   [ Time Frame: 1 week ]

3.  Secondary:   Range of Plasma Concentration of LVT Across All Individuals   [ Time Frame: 72 hours ]

4.  Other Pre-specified:   Number of Participants With Neurologic Sequelae at Discharge   [ Time Frame: day 7 ]

5.  Other Pre-specified:   Number of Subjects With Retinopathy at Enrollment   [ Time Frame: Upon admission ]

6.  Other Pre-specified:   Number of Subjects Exposed to Phenobarbitone Prior to Enrollment   [ Time Frame: 0 hour ]

7.  Other Pre-specified:   Number of Participants Requiring AED During Admission   [ Time Frame: 7 days ]

8.  Other Pre-specified:   Mean Time to Return to a BCS Score Greater Than or Equal to 4   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gretchen Birbeck
Organization: University of Rochester Medical Center
phone: 585-273-4265
e-mail: Gretchen_Birbeck@URMC.Rochester.edu


No publications provided


Responsible Party: Gretchen Birbeck, University of Rochester
ClinicalTrials.gov Identifier: NCT01660672     History of Changes
Other Study ID Numbers: LVT1R01NS074409, 1R01NS074409-01A1
Study First Received: July 19, 2012
Results First Received: August 11, 2014
Last Updated: October 16, 2014
Health Authority: Study Monitoring Committee Malawi:
Malawi's Pharmacy Medicines and Poisons Board (PMPB)Malawi: