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Clinical Trials/NCT00150709
NCT00150709
Completed
Phase 3

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

UCB Pharma0 sites223 target enrollmentStarted: January 26, 1998Last updated:
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ConditionsEpilepsy, Partial
InterventionsLevetiracetam
DrugsLevetiracetam

Overview

Phase
Phase 3
Status
Completed
Sponsor
UCB Pharma
Enrollment
223
Primary Endpoint
Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

N159 PBO/LEV

Experimental

Subjects had previously participated in study N159 in which they had received Placebo (PBO).

Intervention: Levetiracetam (Drug)

N159 LEV/LEV

Experimental

Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).

Intervention: Levetiracetam (Drug)

N01010+N151 LEV/LEV

Experimental

Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).

Intervention: Levetiracetam (Drug)

N01052 LEV/LEV

Experimental

Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).

Intervention: Levetiracetam (Drug)

Outcomes

Primary Outcomes

Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period

Time Frame: During the Treatment Period (an average of 2 years), compared to Baseline

Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

Time Frame: During the Treatment Period (an average of 2 years), compared to Baseline

Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline.

Secondary Outcomes

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

Investigators

Sponsor
UCB Pharma
Sponsor Class
Industry
Responsible Party
Sponsor

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