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A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
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Trial · NCT03340064

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

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ListOutcomeTime frameDescription
PrimaryPercent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6From Baseline (Week 0) to Visit 6 (up to Week 6)
The percent difference in partial seizure frequency per week at Baseline and Study Visit 6 (Week 6) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 6)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
SecondaryPercent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4From Baseline (Week 0) to Visit 4 (up to Week 2)
The percent difference in partial seizure frequency per week at Baseline and Study Visit 4 (Week 2) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 4)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
SecondaryPercent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5From Baseline (Week 0) to Visit 5 (up to Week 4)
The percent difference in partial seizure frequency per week at Baseline and Study Visit 5 (Week 4) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 5)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
SecondaryPercent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
From Baseline (Week 0), Week 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV (up to Week 295), and Safety follow-up (up to Week 295)
Percent difference in partial seizure frequency (PSF) per week at each Analysis Visit: {\[(Number of partial seizures per week at Baseline \[BL\]) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Positive value indicates reduction in PSF from BL. End of study (EOS)/early discontinuation visit (EDV) was based on last EDV and calculation of number of partial seizure per week were based on the period from the previous EDV visit. The mapping of seizure data to Analysis Visits was based on target dates of the visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to the next Analysis Visit (n+1). Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan.
SecondaryPercentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV Week 2, EOS/EDV Week 4, and Safety follow-up (up to Week 295)
Percent difference in PSF per week on adjunctive therapy at BL and each analysis visit: {\[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Percent difference in PSF per week from Baseline for each participant and analysis visit were mapped into 6 categories: \<0%, 0% to \<25%, 25% to \<50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. Positive value in percent difference from Baseline indicates reduction in PSF from Baseline. The mapping of seizure data to Analysis Visits was based on target dates of visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to next Analysis Visit (n+1).
SecondaryPercent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295)
The percent difference in partial seizure frequency per week on monotherapy at Baseline and each analysis visit was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at analysis visit X)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. The maximum duration of study participation in monotherapy participants was shorter than in adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.
SecondaryPercentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295)
Percent difference in PSF per week on monotherapy at BL and each analysis visit: {\[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Percent difference in PFS per week from Baseline for each participant and analysis visit were mapped into 6 categories: \<0%, 0% to \<25%, 25% to \<50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. Maximum duration of study participation in monotherapy participants was shorter than adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.
SecondaryPercentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First PeriodFrom Baseline (Week 0) to Visit 6 (up to Week 6)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation Participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The treatment-emergent adverse events (TEAEs) were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
SecondaryPercentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First PeriodFrom Baseline (Week 0) to Visit 6 (up to Week 6)
A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
SecondaryPercentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First PeriodFrom Baseline (Week 0) to Visit 6 (up to Week 6)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.
SecondaryPercentage of Participants With TEAEs During the Combined First and Second PeriodFrom Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
SecondaryPercentage of Participants With Treatment-emergent SAEs During the Combined First and Second PeriodFrom Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
SecondaryPercentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second PeriodFrom Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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