| Primary | The Maximum Observed Plasma Concentration (Cmax) of Padsevonil (PSL) During the Study | The Cmax for Padsevonil in plasma was expressed in nanograms per milliliter (ng/mL). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Least Squares Mean | 95% Confidence Interval | ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001210(1010 to 1450)
- OG0011670(1390 to 2000)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference. | ANOVA | | | | Geometric mean ratio | 0.725 | | | 2-Sided | 90 | 0.586 | 0.896 | | | | | Other | | |
|
| Primary | The Time to Reach Maximum Concentration (Tmax) for Padsevonil During the Study | The tmax for Padsevonil in plasma was expressed in hours (hr). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Median | Full Range | hr | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Primary | The Area Under the Plasma Concentration Time Curve (AUCtau) Over a Dosing Interval for PSL | The AUCtau for Padsevonil in plasma was expressed in hours times nanograms per milliliter (hr*ng/mL). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Least Squares Mean | 95% Confidence Interval | hr*ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Primary | The Apparent Total Plasma Clearance at Steady-state (CL/Fss) for PSL During the Study | The CL/Fss for Padsevonil in plasma was expressed in liters per hour (L/hr). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL | The trough plasma concentration of MHD with PSL was expressed in micrograms per milliliter (µg/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Trough plasma samples were taken prior to the morning dose of OXC on Day -1, Day 1 through Day 20 (+/-1) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). |
| |
| Secondary | The Maximum Observed Plasma Concentration (Cmax) for UCB1431322-000 During the Study | The Cmax for UCB1431322-000 in plasma was expressed in nanograms per milliliter (ng/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Time to Reach Maximum Concentration (Tmax) for UCB1431322-000 During the Study | The tmax for UCB1431322-000 in plasma was expressed in hours (hr). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Median | Full Range | hr | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1431322-000 During the Study | The AUCtau for UCB1431322-000 in plasma in was expressed in hours times nanograms per milliliter (hr*ng/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Ratio of PSL Metabolite UCB1431322-000 to PSL Based on the Area Under the Curve (AUCtau) During the Study | Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Maximum Observed Plasma Concentration (Cmax) for UCB1447499-000 During the Study | The Cmax for UCB1447499-000 in plasma was expressed in ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Time to Reach Maximum Concentration (Tmax) for UCB1447499-000 During the Study | The tmax for UCB1447499-000 in plasma was expressed in hr. | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Median | Full Range | hr | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1447499-000 During the Study | The AUCtau for UCB1447499-000 in plasma was expressed in hr*ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | The Ratio of PSL Metabolite UCB1447499-000 to PSL Based on the Area Under the Curve (AUCtau) | Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (PK-PPS) | Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS). | | OG001 | Group 2 (Neutral [Control]) (PK-PPS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS. |
|
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During the Study | An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this 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 Full Analysis Set (FAS) consisted of all study participants who signed the ICF and received at least 1 dose of IMP. | Posted | | Number | | percentage of participants | | From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (FAS) | Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Full Analysis Set (FAS). | | OG001 | Group 2 (Neutral [Control]) (FAS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the FAS. |
|
| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that requires treatment parenteral antibiotics or other important medical events which based on medical or scientific judgement could jeopardize the patients, or could require medical or surgical intervention to prevent any of the above. | The Full Analysis Set (FAS) consisted of all study participants who signed the ICF and received at least 1 dose of IMP. | Posted | | Number | | percentage of participants | | From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Inducers) (FAS) | Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Full Analysis Set (FAS). | | OG001 | Group 2 (Neutral [Control]) (FAS) | Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the FAS. |
|