Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152516
First received: September 7, 2005
Last updated: February 8, 2013
Last verified: April 2010
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Purpose
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy, Partial |
Drug: levetiracetam (LEV) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures. |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Secondary Outcome Measures:
- Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
- Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period. [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]
- Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period. [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]
- Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
- Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period [ Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks) ] [ Designated as safety issue: No ]Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
- Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase [ Time Frame: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48) ] [ Designated as safety issue: No ]
The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.
Note: Rates were reported as percentages.
- Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) [ Time Frame: Subjects with up to 24 weeks of exposure ] [ Designated as safety issue: No ]For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
- Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) [ Time Frame: Subjects with greater than 24 weeks of exposure ] [ Designated as safety issue: No ]For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
- Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) [ Time Frame: Subjects with up to 24 weeks of exposure ] [ Designated as safety issue: No ]For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
- Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) [ Time Frame: Subjects with greater than 24 weeks of exposure ] [ Designated as safety issue: No ]For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
- Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period [ Time Frame: greater than or equal to 24 weeks, greater than or equal to 40 weeks ] [ Designated as safety issue: No ]
The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.
The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks.
- Percent of Subjects With Each Seizure Type During the Evaluation Period [ Time Frame: Evaluation period (48 weeks) ] [ Designated as safety issue: No ]
Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).
Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).
Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).
A subject could experience more than one seizure type.
- Investigator Global Evaluation Scale [ Time Frame: End of Evaluation period (week 48 or at point of early discontinuation) ] [ Designated as safety issue: No ]There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
- Parent/Guardian Global Evaluation Scale [ Time Frame: End of Evaluation period (week 48 or at point of early discontinuation) ] [ Designated as safety issue: No ]There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
- Subject (>=8 Years Old) Global Evaluation Scale [ Time Frame: End of Evaluation period (week 48 or at point of early discontinuation) ] [ Designated as safety issue: No ]There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
- Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds) [ Time Frame: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) ] [ Designated as safety issue: Yes ]The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.
- Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds) [ Time Frame: Visit 5 (Week 24) ] [ Designated as safety issue: Yes ]This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
- Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds) [ Time Frame: Visit 7 (week 48) ] [ Designated as safety issue: Yes ]This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
- Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old) [ Time Frame: Visit 5 (week 24) ] [ Designated as safety issue: Yes ]This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
- Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old) [ Time Frame: Visit 7 (week 48) ] [ Designated as safety issue: Yes ]This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
| Enrollment: | 255 |
| Study Start Date: | October 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Levetiracetam |
Drug: levetiracetam (LEV)
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Other Name: Keppra
|
Eligibility| Ages Eligible for Study: | 1 Month to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit
Exclusion Criteria:
- Patients on a ketogenic diet
- Seizures too close together to accurately count
- Pseudoseizures
- Status epilepticus 1 month prior Visit 1
- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152516
Show 85 Study Locations
Show 85 Study LocationsSponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 |
More Information
Additional Information:
Publications:
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00152516 History of Changes |
| Other Study ID Numbers: | N01148, EudraCT number:2004-000200-40 |
| Study First Received: | September 7, 2005 |
| Results First Received: | August 27, 2009 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Mexico: National Institute of Public Health, Health Secretariat Brazil: National Health Surveillance Agency Belgium: Federal Agency for Medicines and Health Products, FAMHP Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency South Africa: Medicines Control Council India: Ministry of Health |
Keywords provided by UCB, Inc.:
|
Partial Onset Seizures levetiracetam Epilepsy Keppra |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Etiracetam |
Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013