NCT01660672

Brief Summary

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing \~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 17, 2014

Completed
Last Updated

September 15, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

July 19, 2012

Results QC Date

August 11, 2014

Last Update Submit

August 3, 2016

Conditions

SeizureEpilepsyCerebral Malaria

Outcome Measures

Primary Outcomes (1)

  • Freedom From Seizure

    Number of subjects free of seizure at 24 hours after initiation of treatment

    24 hours

Secondary Outcomes (2)

  • Toxicity Related to LVT

    1 week

  • Range of Plasma Concentration of LVT Across All Individuals

    72 hours

Other Outcomes (5)

  • Number of Participants With Neurologic Sequelae at Discharge

    day 7

  • Number of Subjects With Retinopathy at Enrollment

    Upon admission

  • Number of Subjects Exposed to Phenobarbitone Prior to Enrollment

    0 hour

  • +2 more other outcomes

Study Arms (1)

LEVETIRACETAM

OTHER

Open label, dose escalation to optimal dose.

Drug: LEVETIRACETAM

Interventions

LEVETIRACETAMDRUG

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.

Also known as: Keppra
LEVETIRACETAM

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Comatose with Blantyre Comas Score ≤ 3
  • P. falciparum parasitemia
  • Active seizure

You may not qualify if:

  • Serum creatinine \> 2mg/dL
  • Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, 3, Malawi

Location

Related Publications (1)

  • Birbeck GL, Herman ST, Capparelli EV, Dzinjalamala FK, Abdel Baki SG, Mallewa M, Toto NM, Postels DG, Gardiner JC, Taylor TE, Seydel KB. A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria. BMC Pediatr. 2019 Nov 1;19(1):399. doi: 10.1186/s12887-019-1766-2.

    PMID: 31672143DERIVED

MeSH Terms

Conditions

SeizuresEpilepsyMalaria, Cerebral

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesCentral Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesMalariaProtozoan InfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Gretchen Birbeck
Organization
University of Rochester Medical Center
Gretchen_Birbeck@URMC.Rochester.edu
585-273-4265

Study Officials

  • Gretchen L Birbeck, M.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2012

First Posted

August 9, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 15, 2016

Results First Posted

October 17, 2014

Record last verified: 2016-08

Locations

MA(1)