Trial record 1 of 2 for:
NCT00175890
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00175890 |
|
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : October 1, 2020
|
Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy, Partial | Drug: Levetiracetam Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | January 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Autosomal dominant partial epilepsy with auditory features
Drug Information available for:
Levetiracetam
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo
Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
|
Other: Placebo
Placebo solution, which is indistinguishable from the Levetiracetam oral solution. |
|
Experimental: Levetiractem
10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
|
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 Name: Keppra |
Primary Outcome Measures :
- 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) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]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.
Secondary Outcome Measures :
- 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) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]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).
- 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 [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.
- 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 [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]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).
- 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 [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.
- 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 [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]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).
- 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 [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ]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.
- Percentage of drop-outs for any reasons during the study [ Time Frame: During the study (up to 20 days) ]
- Percentage of drop-outs due to lack of efficacy during the study [ Time Frame: During the study (up to 20 days) ]
- Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy [ Time Frame: During the study (up to 20 days) ]
- Time to Exit (TTE) during the Evaluation Period [ Time Frame: During Evaluation Period (Day 1 to Day 6) ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Month to 4 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175890
Locations
Show 88 study locations
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00175890 |
| Other Study ID Numbers: |
N01009 2004-000199-14 ( EudraCT Number ) |
| First Posted: | September 15, 2005 Key Record Dates |
| Last Update Posted: | October 1, 2020 |
| Last Verified: | September 2020 |
Keywords provided by UCB Pharma:
|
Partial Onset Seizure levetiracetam Video Electroencephalogram Keppra |
Additional relevant MeSH terms:
|
Seizures Epilepsies, Partial Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Levetiracetam Anticonvulsants Nootropic Agents |