Trial · NCT03340064
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
NCT03340064, Phase 3, Completed, UCB Japan Co. Ltd.; results first posted 2024-07-23
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ConductScience Library. 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. Trials, record NCT03340064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03340064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03340064
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 38 participants, actual
- Lead sponsor
- UCB Japan Co. Ltd.
- Conditions
- Partial Seizures
- Interventions
- Levetiracetam
- First posted
- 2017-11-13
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 | From 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. |
| Secondary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | From 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. |
| Secondary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | From 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. |
| Secondary | Percent 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. |
| Secondary | Percentage 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). |
| Secondary | Percent 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. |
| Secondary | Percentage 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. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period | From 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. |
| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period | From 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. |
| Secondary | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period | From 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 | From Baseline (Week 0) to Visit 6 (up to Week 6) | The Full Analysis Set Adjunctive therapy (FAS\_A) consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | From Baseline (Week 0) to Visit 4 (up to Week 2) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. | percent change | MEDIAN |
| SECONDARY | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | From Baseline (Week 0) to Visit 5 (up to Week 4) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. | percent change | MEDIAN |
| SECONDARY | Percent 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) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, number analyzed signifies participants who were evaluable at specified time points. | percent change | MEDIAN |
| SECONDARY | Percentage 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) | FAS\_A consisted of all participants in SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories ≥50%, ≥75% and 100% are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%. Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan. | percentage of participants | NUMBER |
| SECONDARY | Percent 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 FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were evaluable at specified time points. | percent change | MEDIAN |
| SECONDARY | Percentage 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) | The FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories ≥50%, ≥75% and 100% are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group515
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 | Levetiracetam: Adjunctive Therapy | 24.24 | 95% Confidence Interval -25.48 to 51.85 | percent change | |
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | Levetiracetam: Adjunctive Therapy | 8.62 | Full Range -343.1 to 100.0 | percent change | |
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | Levetiracetam: Adjunctive Therapy | 16.79 | Full Range -414.3 to 100.0 | percent change | |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 8 | 35.53 | Full Range -137.9 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 10 | 59.39 | Full Range -138.2 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 12 | 50.90 | Full Range -167.8 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 15 | 60.29 | Full Range -129.4 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 18 | 82.74 | Full Range -22.3 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 21 | 80.33 | Full Range -44.1 to 100.0 | percent change |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | Levetiracetam: Adjunctive Therapy | Week 24 | 88.44 | Full Range -97.8 to 100.0 | percent change |
1 to 10 of 515Source ClinicalTrials.gov
See all 515 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Period | STARTED | Levetiracetam: Adjunctive Therapy | 32 | |
| First Period | STARTED | Levetiracetam: Monotherapy | 6 | |
| First Period | COMPLETED | Levetiracetam: Adjunctive Therapy | 27 | |
| First Period | COMPLETED | Levetiracetam: Monotherapy | 6 | |
| First Period | NOT COMPLETED | Levetiracetam: Adjunctive Therapy | 5 | |
| First Period | NOT COMPLETED | Levetiracetam: Monotherapy | 0 | |
| Second Period | STARTED | Levetiracetam: Adjunctive Therapy | 27 | |
| Second Period | STARTED | Levetiracetam: Monotherapy | 6 | |
| Second Period | COMPLETED | Levetiracetam: Adjunctive Therapy | 8 | |
| Second Period | COMPLETED | Levetiracetam: Monotherapy | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis allergic | Eye disorders | Levetiracetam: Adjunctive Therapy | 3 | 32 | 4 |
| other | Conjunctivitis allergic | Eye disorders | Levetiracetam: Monotherapy | 2 | 6 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Levetiracetam: Adjunctive Therapy | 8 | 32 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Levetiracetam: Monotherapy | 0 | 6 | 0 |
| other | Constipation | Gastrointestinal disorders | Levetiracetam: Adjunctive Therapy | 6 | 32 | 10 |
| other | Constipation | Gastrointestinal disorders | Levetiracetam: Monotherapy | 1 | 6 | 1 |
| other | Vomiting | Gastrointestinal disorders | Levetiracetam: Adjunctive Therapy | 4 | 32 | 4 |
| other | Vomiting | Gastrointestinal disorders | Levetiracetam: Monotherapy | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Levetiracetam: Adjunctive Therapy | 3 | 32 | 3 |
| other | Nausea | Gastrointestinal disorders | Levetiracetam: Monotherapy | 0 | 6 | 0 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam: Adjunctive Therapy | 0 | 32 |
| Total, all-cause mortality | Levetiracetam: Monotherapy | 0 | 6 |
| Total, other adverse events | Levetiracetam: Adjunctive Therapy | 28 | 32 |
| Total, other adverse events | Levetiracetam: Monotherapy | 6 | 6 |
| Total, serious adverse events | Levetiracetam: Adjunctive Therapy | 18 | 32 |
| Total, serious adverse events | Levetiracetam: Monotherapy | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levetiracetam: Adjunctive Therapy vs Levetiracetam: Monotherapy: deaths from any cause | Trial comparisons |
| Levetiracetam: Adjunctive Therapy vs Levetiracetam: Monotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
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