Phase 3
N=255
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
Epilepsy, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00152516 ↗Enrolled (actual)
255
Serious AEs
18.0%
Results posted
Jan 2010
Primary outcome: Primary: Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. — 51.06; 68.87 percent reduction in seizures Per Week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- levetiracetam (LEV) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. |
51.06; 68.87 | — |
| SECONDARY Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. |
47.44; 66.02 | — |
| SECONDARY Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period. |
2.85; 1.49 | — |
| SECONDARY Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period. |
3.15; 1.91 | — |
| SECONDARY Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period |
0.72; 0.93 | — |
| SECONDARY Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period |
0.69; 0.93 | — |
| SECONDARY Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase |
50.6; 59.8; 65.5; 68.2; 71.8 | — |
| SECONDARY Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) |
61.49 | — |
| SECONDARY Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) |
61.49 | — |
| SECONDARY Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) |
58.41 | — |
| SECONDARY Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More) |
58.41 | — |
| SECONDARY Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period |
16.5; 14.7 | — |
| SECONDARY Percent of Subjects With Each Seizure Type During the Evaluation Period |
88.6; 12.9; 7.1 | — |
| SECONDARY Investigator Global Evaluation Scale |
76.1; 15.3; 8.6 | — |
| SECONDARY Parent/Guardian Global Evaluation Scale |
75.7; 12.6; 11.7 | — |
| SECONDARY Subject (>=8 Years Old) Global Evaluation Scale |
78.9; 15.5; 5.6 | — |
| SECONDARY 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) |
4.8; 4.5 | — |
| SECONDARY 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) |
5; 21; 4 | — |
| SECONDARY 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) |
7; 17; 1 | — |
| SECONDARY 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) |
1; 20; 8 | — |
| SECONDARY 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) |
1; 15; 8 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00152516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.