Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
The study will consist of 2 periods. The First Period (6 weeks drug treatment) is designed to confirm efficacy of levetiracetam (LEV), and the Second Period is designed to evaluate the long-term efficacy and safety of LEV.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Subjects aged 1 month to <6 months will be started on levetiracetam (LEV) 14 mg/kg/day at Visit 3. The dose may be increased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months at 2-week intervals to a maximum dose of 42 mg/kg/day. Subjects aged 6 months to <4 years will be started on LEV 20 mg/kg/day at Visit 3. The dose may be increased by LEV 20 mg/kg/day at 2-week intervals to a maximum dose of 60 mg/kg/day. At Visit 6, subjects may enter the Second Period or enter the Down-Titration Period followed by a Safety Follow-Up Period. Subjects who do not enter the Second Period will be down-titrated. The dose will be decreased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months or by LEV 20 mg/kg/day for subjects aged 6 months to <4 years at 2-week intervals to 0 mg/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 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. | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0100 15 | Fukuoka | Japan | ||||
| EP0100 3 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Participant Flow refers to the Safety Set Adjunctive therapy (SS_A) and Safety Set Monotherapy (SS_M).
The study started to enroll participants in November 2017 and concluded in July 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam: Adjunctive Therapy | Participants aged 1 month to less than (<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2023 | Dec 18, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From Baseline (Week 0) to Visit 4 (up to Week 2) |
| Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | 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. | From Baseline (Week 0) to Visit 5 (up to Week 4) |
| Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | 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. | 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) |
| 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 | 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). | 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 Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy | 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. | 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) |
| 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 | 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. | 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) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period | 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. | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period | 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. | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period | 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. | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| Percentage of Participants With TEAEs During the Combined First and Second Period | 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. | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
| Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period | 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. | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
| Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period | 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. | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
| Hamamatsu |
| Japan |
| EP0100 6 | Izumi | Japan |
| Ep0100 20 | Kobe | Japan |
| EP0100 2 | Kodaira | Japan |
| Ep0100 21 | Kofu | Japan |
| EP0100 7 | Kōshi | Japan |
| EP0100 9 | Nagakute | Japan |
| EP0100 5 | Niigata | Japan |
| Ep0100 14 | Okayama | Japan |
| Ep0100 13 | Osaka | Japan |
| Ep0100 12 | Ōbu | Japan |
| Ep0100 11 | Ōmura | Japan |
| Ep0100 18 | Saitama | Japan |
| EP0100 4 | Sapporo | Japan |
| Ep0100 10 | Sendai | Japan |
| Ep0100 19 | Sendai | Japan |
| Ep0100 16 | Shinjuku-ku | Japan |
| Ep0100 17 | Shinjuku-ku | Japan |
| EP0100 1 | Shizuoka | Japan |
| Ep0100 22 | Toyoake | Japan |
| FG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Second Period |
|
|
Baseline Characteristics refer to the SS_A and SS_M. 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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam: Adjunctive Therapy | Participants aged 1 month to less than (<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator. |
| BG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 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. | 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. | Posted | Median | 95% Confidence Interval | percent change | From Baseline (Week 0) to Visit 6 (up to Week 6) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | 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. | The FAS_A consisted of all participants in the SS_A who had at least 1 post-Baseline efficacy assessment. | Posted | Median | Full Range | percent change | From Baseline (Week 0) to Visit 4 (up to Week 2) |
| |||||||||||||||||||||||||||
| Secondary | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | 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. | The FAS_A consisted of all participants in the SS_A who had at least 1 post-Baseline efficacy assessment. | Posted | Median | Full Range | percent change | From Baseline (Week 0) to Visit 5 (up to Week 4) |
| |||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | 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. | 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. | Posted | Median | Full Range | percent change | 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) |
| |||||||||||||||||||||||||||
| 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 | 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). | 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. | Posted | Number | percentage of participants | 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) |
| ||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy | 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. | 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. | Posted | Median | Full Range | percent change | 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) |
| |||||||||||||||||||||||||||
| 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 | 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. | 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%. | Posted | Number | percentage of participants | 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) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to Visit 6 (up to Week 6) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TEAEs During the Combined First and Second Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) |
|
From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
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 were analyzed and reported for SS_A and SS_M.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam: Adjunctive Therapy | Participants aged 1 month to less than (<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator. | 0 | 32 | 18 | 32 | 28 | 32 |
| EG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. | 0 | 6 | 2 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Selective eating disorder | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Epilepsy surgery | Surgical and medical procedures | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oral contusion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urticaria thermal | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2022 | Jul 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Approved Drug Available For Indication |
|
| Protocol-Specified Withdrawal Criterion Met |
|
| 24 months - <12 years |
|
| Male |
|
|
|
|
|
|
|
| OG000 |
| Levetiracetam: Adjunctive Therapy |
Participants aged 1 month to less than (<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
|
|
Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|
| OG001 | Levetiracetam: Monotherapy | Participants aged 1 month to < 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to <4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to <6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months <4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. |
|
|