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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002194-54 | EudraCT Number |
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Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
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The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral contraceptive | Experimental | Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2. |
|
| Oral contraceptive + padsevonil | Experimental | Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Padsevonil | Drug | Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1 | Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
| Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1 | Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
| Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2 | Cmax is maximum observed plasma concentration of ethinylestradiol. | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
| Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2 | Cmax is maximum observed plasma concentration of levonorgestrel. | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1 | Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1 | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Participant has a history of discontinued use of oral contraceptives (OC) for medical reasons
Participant has any medical reason that would contraindicate the administration of OC (per label)
Participant has used any of the following within the specified time period prior to first dose of study medication:
Participant has other relevant gynecological disorders (such as premature ovarian failure or endometriosis)
Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline (Day -1) that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any study participant with any of the following findings will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0035 001 | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38932723 | Derived | Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9. |
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Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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Participant flow refers to the Safety Set (SS). No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.
The study started to enroll study participants in October 2019 and concluded in May 2020. No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Sequence A | Participants received padsevonil (PSL) tablets 100 milligrams (mg) up-titrated to 400 mg, orally twice daily (bid) from Day 1 to 6 followed by padsevonil 400 mg bid on Day 7 to 14 along with a single dose of oral contraceptive (OC) Microgynon® 30 (ethinylestradiol 30 microgram [mcg] + levonorgestrel 150 mcg) tablet on Day 13 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 15 to 19 during first Treatment Period. Participants received a single dose of OC tablet on Day 34 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods. |
| FG001 | Part 1 Sequence B | Participants received a single dose of OC tablet on Day 1 during first Treatment Period. Participants received padsevonil tablets 100 mg up-titrated to 400 mg, bid on Day 18 to 23 followed by padsevonil 400 mg bid on Day 24 to 31 along with a single dose of OC tablet on Day 30 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 32 to 36 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Characteristics refer to Safety Set which included study participants who received at least 1 dose of study medication (PSL or OC). No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Sequence A | Participants received padsevonil (PSL) tablets 100 milligrams (mg) up-titrated to 400 mg, orally twice daily (bid) from Day 1 to 6 followed by padsevonil 400 mg bid on Day 7 to 14 along with a single dose of oral contraceptive (OC) Microgynon® 30 (ethinylestradiol 30 microgram [mcg] + levonorgestrel 150 mcg) tablet on Day 13 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 15 to 19 during first Treatment Period. Participants received a single dose of OC tablet on Day 34 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1 | Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Pharmacokinetic Set (PKS) included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. | Posted | Geometric Mean | 95% Confidence Interval | picograms per milliliter (pg/mL) | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
|
From Baseline up to Safety Follow-Up during Treatment Sequences A and B in Part 1 (up to Day 46)
Treatment-emergent AEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. No study participants started Part 2 due to the COVID-19 pandemic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 PSL + Oral Contraceptive (SS) | After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Safety Set (SS). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA22.1 | Non-systematic Assessment |
The study was terminated on 22 May 2020 because the program developing padsevonil in focal-onset seizures was stopped.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2020 | May 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2020 | May 14, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708857 | padsevonil |
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| Microgynon 30® | Drug | Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg |
|
| Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol. | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel. | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
| From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
| Percentage of Participants With Serious TEAEs in Part 1 | Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above. | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
| Percentage of Participants With TEAEs in Part 2 | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
| Percentage of Participants With Serious TEAEs in Part 2 | Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above. | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
| Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1 | Maximum observed plasma concentration of padsevonil at steady-state was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
| Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2 | Cmax,ss is the steady state plasma concentration of padsevonil. | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
| Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1 | Area under the concentration-time curve over a dosing interval from time 0 to tau for padsevonil was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
| Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2 | AUC0-tau is area under the concentration-time curve over a dosing interval from time 0 to tau of padsevonil. | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
| BG001 | Part 1 Sequence B | Participants received a single dose of OC tablet on Day 1 during first Treatment Period. Participants received padsevonil tablets 100 mg up-titrated to 400 mg, bid on Day 18 to 23 followed by padsevonil 400 mg bid on Day 24 to 31 along with a single dose of OC tablet on Day 30 and, then padsevonil down-titrated from 400 mg to 100 mg bid from Day 32 to 36 during second Treatment Period. There was a Washout Period of 14 days between the two Treatment Periods. |
| BG002 | Total Title |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Part 1 PSL + Oral Contraceptive (PKS) | After OC intake on Day 13 with PSL through Day 34 (prior to OC intake) at Sequence A and after OC intake on Day 30 with PSL through Day 43 at Sequence B attributed to PSL + OC Treatment Period. Participants formed the Pharmacokinetic Set (PKS). |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1 | Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2 | Cmax is maximum observed plasma concentration of ethinylestradiol. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2 | Cmax is maximum observed plasma concentration of levonorgestrel. | No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated. | Posted | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1 | Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | hours*picograms per milliliter (h*pg/mL) | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. | Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | h*pg/mL | Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2 | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B |
|
|
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1 | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. | Safety Set included study participants who received at least 1 dose of study medication (PSL or OC). | Posted | Number | percentage of participants | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
|
|
|
| Secondary | Percentage of Participants With Serious TEAEs in Part 1 | Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above. | Safety Set included study participants who received at least 1 dose of study medication (PSL or OC). | Posted | Number | percentage of participants | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
|
|
|
| Secondary | Percentage of Participants With TEAEs in Part 2 | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
|
|
| Secondary | Percentage of Participants With Serious TEAEs in Part 2 | Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
|
|
| Secondary | Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1 | Maximum observed plasma concentration of padsevonil at steady-state was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. | Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. | Posted | Geometric Mean | 95% Confidence Interval | nanograms per milliliter (ng/mL) | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
|
|
|
|
| Secondary | Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2 | Cmax,ss is the steady state plasma concentration of padsevonil. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1 | Area under the concentration-time curve over a dosing interval from time 0 to tau for padsevonil was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. | Pharmacokinetic Set included all study participants who had no important protocol deviations affecting the PK of EE, LN, or PSL and its metabolite and for whom at least 1 measurable concentration existed. | Posted | Geometric Mean | 95% Confidence Interval | hours*nanograms per milliliter (h*ng/mL) | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2 | AUC0-tau is area under the concentration-time curve over a dosing interval from time 0 to tau of padsevonil. | Analysis of this outcome measure was not performed because no study participants started Part 2 due to the COVID-19 pandemic. Later, the study was terminated. | Posted | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 12 |
| 14 |
| EG001 | Part 1 Oral Contraceptive Alone (SS) | After OC intake on Day 34 through Day 41 at Sequence A and OC intake on Day 1 through Day 18 (prior to PSL intake) at Sequence B attributed to OC Alone Treatment Period. Participants formed the SS. | 0 | 14 | 0 | 14 | 7 | 14 |
| EG002 | Part 1 PSL Alone (SS) | First intake of PSL through Day 13 (prior to OC intake) at Sequence A and PSL intake on Day 18 through Day 30 (prior to OC intake) at Sequence B attributed to PSL Alone Treatment Period. Participants formed the SS. | 0 | 14 | 0 | 14 | 14 | 14 |
| Ocular hyperaemia | Eye disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Behaviour disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Flat affect | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Suicide threat | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Communication disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA22.1 | Non-systematic Assessment |
|
Not provided