A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.

Epilepsy, Partial Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175890
• Other study ID #: N01009
• Secondary ID: 2004-000199-14
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: January 2007

Study information

• Verified date: September 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 4 Years

Eligibility

Inclusion Criteria:

• Pediatric patients from 1 month to less than 4 years of age

• Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening

• Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening

Exclusion Criteria:

• A ketogenic diet

• Previous exposure to levetiracetam

• Seizures too close together to count accurately

• Treatable seizure etiology

• Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease

• Diagnosis of a terminal illness

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy, Partial
• Seizures

Intervention

Drug:
• Levetiracetam
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.

Other:
• Placebo
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  United Kingdom, 

References & Publications (1)

Piña-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)	Responder Rate is defined as the number of subjects with a = 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)	Responder Rate is defined as the number of subjects with a = 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG	A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG	A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG	A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG	A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old	A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures.	48-hours in Evaluation Period and 48-hours in Selection Period
Secondary	Percentage of drop-outs for any reasons during the study		During the study (up to 20 days)
Secondary	Percentage of drop-outs due to lack of efficacy during the study		During the study (up to 20 days)
Secondary	Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy		During the study (up to 20 days)
Secondary	Time to Exit (TTE) during the Evaluation Period	For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.	During Evaluation Period (Day 1 to Day 6)

External Links

•   Clinical Study Summary on UCB.com