Clinical trial NCT00150709: A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Official title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Epilepsy
Pediatric
Partial onset epilepsy
Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 223
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
measure: Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
Secondary outcomes:
measure: Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
measure: Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
measure: At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
measure: At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years), compared to Baseline
measure: Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years)
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0)
timeFrame: Day 0 (beginning day of the maintenance phase)
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months)
timeFrame: Day 1 - <= 2 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months)
timeFrame: > 2 months - <= 4 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months)
timeFrame: > 4 months - <= 6 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months)
timeFrame: > 6 months - <= 8 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months)
timeFrame: > 8 months - <= 10 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months)
timeFrame: > 10 months - <= 12 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months)
timeFrame: > 12 months - <= 14 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months)
timeFrame: > 14 months - <= 16 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months)
timeFrame: > 16 months - <= 18 months of the Maintenance Phase
measure: Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months)
timeFrame: > 18 months - <= 20 months of the Maintenance Phase
measure: Number of Seizures by Type During the Treatment Period
timeFrame: During the Treatment Period (an average of 2 years)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1
timeFrame: Visit 1 (Screening Visit (Week 0))
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1
timeFrame: Titration Visit 1 (Week 2)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2
timeFrame: Titration Visit 2 (Week 4)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3
timeFrame: Titration Visit 3 (Week 6)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2
timeFrame: Visit 2 (Month 2)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3
timeFrame: Visit 3 (Month 4)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4
timeFrame: Visit 4 (Month 6)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5
timeFrame: Visit 5 (Month 9)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6
timeFrame: Visit 6 (Month 12)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7
timeFrame: Visit 7 (Month 15)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8
timeFrame: Visit 8 (Month 18)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9
timeFrame: Visit 9 (Month 21)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10
timeFrame: Visit 10 (Month 24)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11
timeFrame: Visit 11 (Month 27)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12
timeFrame: Visit 12 (Month 30)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13
timeFrame: Visit 13 (Month 33)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14
timeFrame: Visit 14 (Month 36)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15
timeFrame: Visit 15 (Month 39)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16
timeFrame: Visit 16 (Month 42)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17
timeFrame: Visit 17 (Month 45)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18
timeFrame: Visit 18 (Month 48)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19
timeFrame: Visit 19 (Month 51)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20
timeFrame: Visit 20 (Month 54)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21
timeFrame: Visit 21 (Month 57)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22
timeFrame: Visit 22 (Month 60)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23
timeFrame: Visit 23 (Month 63)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24
timeFrame: Visit 24 (Month 66)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25
timeFrame: Visit 25 (Month 69)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26
timeFrame: Visit 26 (Month 72)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27
timeFrame: Visit 27 (Month 75)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28
timeFrame: Visit 28 (Month 78)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29
timeFrame: Visit 29 (Month 81)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30
timeFrame: Visit 30 (Month 84)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31
timeFrame: Visit 31 (Month 87)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit
timeFrame: Withdrawal visit (up to Month 90)
measure: Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit
timeFrame: Final visit (up to Month 90)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1
timeFrame: Visit 1 (Screening Visit (Week 0))
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1
timeFrame: Titration Visit 1 (Week 2)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2
timeFrame: Titration Visit 2 (Week 4)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3
timeFrame: Titration Visit 3 (Week 6)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2
timeFrame: Visit 2 (Month 2)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3
timeFrame: Visit 3 (Month 4)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4
timeFrame: Visit 4 (Month 6)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5
timeFrame: Visit 5 (Month 9)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6
timeFrame: Visit 6 (Month 12)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7
timeFrame: Visit 7 (Month 15)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8
timeFrame: Visit 8 (Month 18)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9
timeFrame: Visit 9 (Month 21)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10
timeFrame: Visit 10 (Month 24)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11
timeFrame: Visit 11 (Month 27)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12
timeFrame: Visit 12 (Month 30)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13
timeFrame: Visit 13 (Month 33)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14
timeFrame: Visit 14 (Month 36)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15
timeFrame: Visit 15 (Month 39)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16
timeFrame: Visit 16 (Month 42)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17
timeFrame: Visit 17 (Month 45)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18
timeFrame: Visit 18 (Month 48)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19
timeFrame: Visit 19 (Month 51)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20
timeFrame: Visit 20 (Month 54)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21
timeFrame: Visit 21 (Month 57)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22
timeFrame: Visit 22 (Month 60)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23
timeFrame: Visit 23 (Month 63)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24
timeFrame: Visit 24 (Month 66)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25
timeFrame: Visit 25 (Month 69)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26
timeFrame: Visit 26 (Month 72)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27
timeFrame: Visit 27 (Month 75)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28
timeFrame: Visit 28 (Month 78)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29
timeFrame: Visit 29 (Month 81)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30
timeFrame: Visit 30 (Month 84)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31
timeFrame: Visit 31 (Month 87)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit
timeFrame: Withdrawal visit (up to Month 90)
measure: Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit
timeFrame: Final visit (up to Month 90)
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: