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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05610085




Registration number
NCT05610085
Ethics application status
Date submitted
27/10/2022
Date registered
9/11/2022

Titles & IDs
Public title
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Scientific title
A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures
Secondary ID [1] 0 0
FD-R-6335
Universal Trial Number (UTN)
Trial acronym
NEOLEV3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Seizure 0 0
Neonatal Encephalopathy 0 0
Hypoxic-Ischemic Encephalopathy 0 0
Seizure Newborn 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levetiracetam Injection
Treatment: Drugs - Phenobarbital Sodium Injection

Experimental: Dose escalation with LEV - Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study).

Active comparator: Standard of care Phenobarbital - Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg


Treatment: Drugs: Levetiracetam Injection
Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital

Treatment: Drugs: Phenobarbital Sodium Injection
Standard of care for neonatal seizures
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint is the maximum safe and tolerated dose of Levetiracetam
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
Levetiracetam CL
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Levetiracetam Vd
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Adverse event rates
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Long-term outcome
Timepoint [4] 0 0
8 years
Secondary outcome [5] 0 0
Seizure burden reduction
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Seizure freedom rates
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Estimate of efficacy of higher dose LEV
Timepoint [7] 0 0
4 years

Eligibility
Key inclusion criteria
* at risk for seizures or suspected to be having seizures;
* all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;
* Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);
* weight > 2200g.
* Parental ability to comprehend and provide written informed consent
Minimum age
No limit
Maximum age
1 Month
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 30 minutes/hour or more in phase 3;
* Renal failure defined as anuria in the first 24 hours of life;
* Subjects in whom death seems imminent;
* Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
133
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, San Diego
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Minnesota
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Rady Children's Hospital, San Diego
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Auckland City Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Auckland, New Zealand
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Middlemore Hospital, New Zealand
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sonya G Wang, M.D.
Address 0 0
University of Minnesota
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sonya G Wang, M.D.
Address 0 0
Country 0 0
Phone 0 0
612-301-1454
Fax 0 0
Email 0 0
sgwang@umn.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05610085