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

NCT01982812 | Completed Phase 2 Results DMC

• 2 other identifiers: 7R01NS074409-02R01NS074409
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Seizure; Epilepsy; Cerebral Malaria

Outcome Measures

Primary Outcomes (1)

• Minutes With Seizure on EEG

  Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.

  72 hours

Secondary Outcomes (3)

• Required Additional AED

  7 days

• Mean Time From Admission to BCS >/= 4

  7 days

• Sequelae

  7 days

Study Arms (2)

Oral Levetiracetam

EXPERIMENTAL

Oral Levetiracetam administered by NG tube.

Drug: Oral Levetiracetam

Standard AED

ACTIVE COMPARATOR

Standard AED regimen

Drug: Standard AED

Interventions

Oral Levetiracetam DRUG

liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days

Also known as: Keppra

Oral Levetiracetam

Standard AED DRUG

Active comparitor, Standard AED

Also known as: Standard regimen of AED therapy

Standard AED

Eligibility Criteria

• Age: 24 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Comatose with Blantyre Comas Score ≤ 2
• P. falciparum parasitemia via thick blood film or rapid diagnostic test
• Active seizure in past 24 hours

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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

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: 31672143 DERIVED

MeSH Terms

Conditions

Seizures; Epilepsy; Malaria, Cerebral

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Central Nervous System Protozoal Infections; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Malaria; Protozoan Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gretchen L. Birbeck
• Organization: University of Rochester

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 13, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

MA (1)