Phase 3
N=223
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Epilepsy, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00150709 ↗Enrolled (actual)
223
Serious AEs
33.2%
Results posted
Feb 2024
Primary outcome: Primary: Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period — -66.4; -47.8; -66.4 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levetiracetam (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period |
-66.4; -47.8; -66.4 | — |
| PRIMARY Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period |
-66.4; -45.7; -65.9 | — |
| SECONDARY Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period |
-2.1; -1.6; -1.5 | — |
| SECONDARY Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period |
-2.1; -1.5; -1.1 | — |
| SECONDARY At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period |
58.4; 47.7; 62.2 | — |
| SECONDARY At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period |
58.4; 46.6; 62.2 | — |
| SECONDARY Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period |
74; 73; 40; 10 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) |
74.0; 64.0; 75.0; 38.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) |
16.4; 15.1; 27.5; 23.1 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) |
12.3; 12.8; 17.5; 23.1 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) |
11.0; 9.3; 15.0; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) |
8.2; 4.7; 12.5; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) |
5.5; 3.5; 10.0; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) |
1.4; 3.5; 7.5; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) |
1.4; 2.3; 5.0; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) |
1.4; 2.3; 5.0; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) |
1.4; 2.3; 2.5; 11.5 | — |
| SECONDARY Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) |
1.4; 2.3; 2.5; 11.5 | — |
| SECONDARY Number of Seizures by Type During the Treatment Period |
42132; 70121; 24232; 19914; 39147; 57464 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 |
7.7; 11.2; 29.3; 0.0; 21.8; 18.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 |
14.9; 6.1; 14.9; 14.6; 32.4; 18.3 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 |
10.7; 13.1; 20.0; 8.3; 20.0; 15.5 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 |
10.4; 4.1; 14.9; 8.2; 17.9; 21.9 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 |
4.1; 8.3; 20.5; 16.7; 15.1; 14.3 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 |
4.4; 6.5; 15.8; 20.0; 7.4; 3.9 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 |
4.8; 4.0; 14.3; 10.0; 6.3; 10.7 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 |
3.4; 6.2; 3.1; 0.0; 13.6; 6.2 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 |
5.6; 1.6; 10.7; 11.1; 16.7; 13.1 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 |
12.8; 9.6; 3.6; 0.0; 4.3; 13.5 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 |
10.0; 3.9; 3.6; 16.7; 5.0; 11.8 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 |
5.1; 8.2; 14.8; 0.0; 7.7; 14.3 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 |
5.7; 6.4; 4.0; 0.0; 8.6; 12.8 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 |
9.4; 2.3; 4.5; 0.0; 9.4; 6.8 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 |
6.7; 5.1; 0.0; 0.0; 6.7; 15.4 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 |
3.8; 3.3; 0.0; 0.0; 7.7; 6.7 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 |
13.3; 4.2; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 |
6.7; 0.0; 0.0; 0.0; 0.0; 14.3 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 |
0.0; 0.0; 0.0; 0.0; 5.6; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 |
7.7; 11.8; 0.0; 0.0; 0.0; 16.7 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 |
7.7; 15.4; 16.7; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 |
9.1; 7.7; 0.0; 0.0; 7.7; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 |
0.0; 8.3; 0.0; 9.1; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 |
22.2; 0.0; 0.0; 0.0; 12.5; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 |
33.3; 0.0; 0.0; 0.0; 0.0; 20.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 |
0.0; 0.0; 0.0; 0.0; 0.0; 20.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 |
0.0; 20.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 |
0.0; 25.0; 0.0; 75.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 |
0.0; 25.0; 0.0; 75.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 |
0.0; 0.0; 0.0; 75.0; 25.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit |
5.9; 0.0; 0.0; 0.0; 5.9; 7.1 | — |
| SECONDARY Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit |
4.3; 3.7; 2.4; 7.7; 11.6; 6.2 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 |
12.8; 18.0; 29.3; 0.0; 16.7; 15.7 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 |
17.6; 11.0; 18.9; 11.0; 32.4; 17.1 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 |
17.3; 16.7; 16.0; 10.7; 20.0; 15.5 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 |
10.4; 4.1; 9.0; 12.3; 20.9; 27.4 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 |
6.8; 13.1; 25.6; 16.7; 17.8; 11.9 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 |
8.8; 6.5; 18.4; 20.0; 5.9; 6.5 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 |
4.8; 8.0; 20.0; 20.0; 7.9; 6.7 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 |
6.8; 10.8; 9.4; 11.1; 10.2; 6.2 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 |
7.4; 8.2; 14.3; 11.1; 9.3; 13.1 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 |
10.6; 19.2; 7.1; 0.0; 10.6; 9.6 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 |
5.0; 15.7; 7.1; 16.7; 7.5; 9.8 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 |
10.3; 12.2; 18.5; 0.0; 7.7; 10.2 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 |
8.6; 8.5; 12.0; 0.0; 5.7; 8.5 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 |
9.4; 9.1; 9.1; 0.0; 9.4; 4.5 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 |
6.7; 7.7; 0.0; 0.0; 13.3; 12.8 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 |
7.7; 3.3; 0.0; 0.0; 23.1; 6.7 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 |
20.0; 4.2; 0.0; 0.0; 4.2; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 |
6.7; 0.0; 0.0; 6.7; 0.0; 14.3 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 |
7.1; 0.0; 0.0; 21.4; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 |
15.4; 11.8; 0.0; 0.0; 0.0; 16.7 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 |
0.0; 15.4; 16.7; 0.0; 7.7; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 |
9.1; 7.7; 0.0; 0.0; 7.7; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 |
9.1; 8.3; 0.0; 9.1; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 |
22.2; 0.0; 0.0; 0.0; 0.0; 20.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 |
33.3; 0.0; 20.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 |
0.0; 0.0; 0.0; 50.0; 0.0; 20.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 |
0.0; 20.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 |
0.0; 25.0; 0.0; 75.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 |
0.0; 25.0; 0.0; 75.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 |
0.0; 0.0; 0.0; 75.0; 25.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 |
0.0; 0.0; 0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit |
5.9; 7.1; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit |
8.7; 7.4; 4.9; 7.7; 14.5; 8.6 | — |
Summary
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.
Eligibility Criteria
Inclusion Criteria
- Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
- Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.
Exclusion Criteria
- Not be on a ketogenic diet (during the course of this study).
- Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).
Data sourced from ClinicalTrials.gov (NCT00150709). 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.