A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Terminated
CT.gov ID
NCT04131517
Collaborator
(none)
14
1
2
7
2
Study Details
Study Description
Brief Summary
The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Actual Study Start Date
:
Oct 23, 2019
Actual Primary Completion Date
:
May 22, 2020
Actual Study Completion Date
:
May 22, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oral contraceptive Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2. |
Drug: Microgynon 30®
Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg
|
| Experimental: Oral contraceptive + padsevonil Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2. |
Drug: Padsevonil
Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2)
Drug: Microgynon 30®
Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1 [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]
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.
- Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1 [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]
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.
- Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2 [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]
Cmax is maximum observed plasma concentration of ethinylestradiol.
- Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2 [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]
Cmax is maximum observed plasma concentration of levonorgestrel.
- Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1 [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 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
- Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1 [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]
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.
- Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2 [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]
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol.
- Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2 [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]
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel.
Secondary Outcome Measures
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1 [From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)]
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.
- Percentage of Participants With Serious TEAEs in Part 1 [From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)]
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.
- Percentage of Participants With TEAEs in Part 2 [From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)]
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.
- Percentage of Participants With Serious TEAEs in Part 2 [From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)]
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.
- Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1 [Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)]
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.
- Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2 [Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)]
Cmax,ss is the steady state plasma concentration of padsevonil.
- Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1 [Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)]
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.
- Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2 [Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)]
AUC0-tau is area under the concentration-time curve over a dosing interval from time 0 to tau of padsevonil.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Participant must be aged 18 years of age or greater, at the time of signing the informed consent
-
Participant must be a premenopausal female with no indication of abnormal or gestational/lactational hypothalamic-pituitary-ovarian function. Menopause will be defined for the purpose of this study as amenorrhea of ≥12 months for which no other reason has been identified
-
Participant must not be pregnant or breastfeeding. Participant must agree to use an effective form of contraception (other than hormonal methods) for the duration of the Treatment Period and for at least 90 days (or 5 terminal half-lives) after the last dose of study medication
-
Participant must be in good physical and mental health as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
-
Participant must have body weight of at least 45 kg and body mass index within the range 18 to 30 kg/m^2 (inclusive)
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:
-
Oral contraceptive or oral hormone replacement therapy within prior 30 days
-
Implanted hormonal contraceptives within prior 6 months
-
Injectable contraceptives within prior 12 months
-
Topical controlled-delivery contraceptives within prior 3 months
-
Hormone-releasing intrauterine devices ('coils') within prior 3 months
-
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:
-
QT interval corrected for heart rate using Bazett's formula (QTcB) or Fridericia's formula (QTcF) >450 ms in 2 of 3 ECG recordings;
-
other conduction abnormalities (defined as PR interval ≥220 ms);
-
irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats. In case of an out-of-range result, 1 repeat will be allowed. If the result is out-of-range again, the study participant cannot be included
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Up0035 001 | London | United Kingdom |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
UCB Biopharma SRL
ClinicalTrials.gov Identifier:
NCT04131517
Other Study ID Numbers:
- UP0035
- 2019-002194-54
First Posted:
Oct 18, 2019
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by UCB Biopharma SRL
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Part 1 Sequence A | Part 1 Sequence B |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 7 | 7 |
| COMPLETED | 7 | 7 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part 1 Sequence A | Part 1 Sequence B | Total Title |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | |
| Overall Participants | 7 | 7 | 14 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
7
100%
|
7
100%
|
14
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.6
(7.3)
|
30.0
(9.2)
|
35.3
(9.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
100%
|
7
100%
|
14
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Black |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| White |
7
100%
|
6
85.7%
|
13
92.9%
|
| Other/Mixed |
0
0%
|
1
14.3%
|
1
7.1%
|
Outcome Measures
| Title | Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 Oral Contraceptive Alone (PKS) | Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Arm/Group Description | 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 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). |
| Measure Participants | 14 | 14 |
| Geometric Mean (95% Confidence Interval) [picograms per milliliter (pg/mL)] |
41.17
|
42.83
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 1.0404 | |
| Confidence Interval |
(2-Sided) 90% 0.94156 to 1.1497 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 Oral Contraceptive Alone (PKS) | Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Arm/Group Description | 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 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). |
| Measure Participants | 14 | 14 |
| Geometric Mean (95% Confidence Interval) [pg/mL] |
2868
|
2560
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 0.89272 | |
| Confidence Interval |
(2-Sided) 90% 0.76892 to 1.0364 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2 |
|---|---|
| Description | Cmax is maximum observed plasma concentration of ethinylestradiol. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
| Title | Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2 |
|---|---|
| Description | Cmax is maximum observed plasma concentration of levonorgestrel. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
| Title | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 Oral Contraceptive Alone (PKS) | Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Arm/Group Description | 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 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). |
| Measure Participants | 13 | 13 |
| Geometric Mean (95% Confidence Interval) [hours*picograms per milliliter (h*pg/mL)] |
614.6
|
629.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 1.0276 | |
| Confidence Interval |
(2-Sided) 90% 0.95544 to 1.1052 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 Oral Contraceptive Alone (PKS) | Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Arm/Group Description | 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 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). |
| Measure Participants | 5 | 8 |
| Geometric Mean (95% Confidence Interval) [h*pg/mL] |
NA
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 0.88808 | |
| Confidence Interval |
(2-Sided) 90% 0.52185 to 1.5113 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2 |
|---|---|
| Description | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
| Title | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2 |
|---|---|
| Description | AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
| Title | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set included study participants who received at least 1 dose of study medication (PSL or OC). |
| Arm/Group Title | Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) |
|---|---|---|---|
| Arm/Group Description | 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). | 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. | 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. |
| Measure Participants | 14 | 14 | 14 |
| Number [percentage of participants] |
85.7
1224.3%
|
50.0
714.3%
|
100.0
714.3%
|
| Title | Percentage of Participants With Serious TEAEs in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set included study participants who received at least 1 dose of study medication (PSL or OC). |
| Arm/Group Title | Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) |
|---|---|---|---|
| Arm/Group Description | 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). | 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. | 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. |
| Measure Participants | 14 | 14 | 14 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With TEAEs in Part 2 |
|---|---|
| Description | 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. |
| Time Frame | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive | Part 2 PSL Alone |
|---|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 | 0 |
| Title | Percentage of Participants With Serious TEAEs in Part 2 |
|---|---|
| Description | 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. |
| Time Frame | From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 Oral Contraceptive Alone | Part 2 PSL + Oral Contraceptive | Part 2 PSL Alone |
|---|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 | 0 |
| Title | Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 PSL + Oral Contraceptive (PKS) | Part 1 PSL Alone (PKS) |
|---|---|---|
| Arm/Group Description | 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). | 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 PKS. |
| Measure Participants | 14 | 14 |
| Geometric Mean (95% Confidence Interval) [nanograms per milliliter (ng/mL)] |
2008
|
2083
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 0.96378 | |
| Confidence Interval |
(2-Sided) 90% 0.85043 to 1.0922 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2 |
|---|---|
| Description | Cmax,ss is the steady state plasma concentration of padsevonil. |
| Time Frame | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 PSL + Oral Contraceptive | Part 2 PSL Alone |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
| Title | Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1 |
|---|---|
| Description | 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. |
| Time Frame | Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 1 PSL + Oral Contraceptive (PKS) | Part 1 PSL Alone (PKS) |
|---|---|---|
| Arm/Group Description | 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). | 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 PKS. |
| Measure Participants | 14 | 14 |
| Geometric Mean (95% Confidence Interval) [hours*nanograms per milliliter (h*ng/mL)] |
9612
|
9925
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1 Oral Contraceptive Alone (PKS), Part 1 PSL + Oral Contraceptive (PKS) |
|---|---|---|
| Comments | The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect. | |
| Type of Statistical Test | Other | |
| Comments | A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric LS Mean ratio |
| Estimated Value | 0.96842 | |
| Confidence Interval |
(2-Sided) 90% 0.91888 to 1.0206 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2 |
|---|---|
| Description | AUC0-tau is area under the concentration-time curve over a dosing interval from time 0 to tau of padsevonil. |
| Time Frame | Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Part 2 PSL + Oral Contraceptive | Part 2 PSL Alone |
|---|---|---|
| Arm/Group Description | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. | No study participants started Part 2 due to the COVID-19 pandemic. Later, study was terminated. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | From Baseline up to Safety Follow-Up during Treatment Sequences A and B in Part 1 (up to Day 46) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) | |||
| Arm/Group Description | 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). | 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. | 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. | |||
All Cause Mortality |
||||||
| Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) | |||
Serious Adverse Events |
||||||
| Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Part 1 PSL + Oral Contraceptive (SS) | Part 1 Oral Contraceptive Alone (SS) | Part 1 PSL Alone (SS) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/14 (85.7%) | 7/14 (50%) | 14/14 (100%) | |||
| Cardiac disorders | ||||||
| Palpitations | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Eye disorders | ||||||
| Ocular hyperaemia | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Vision blurred | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Abdominal pain lower | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Nausea | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 2/14 (14.3%) | 2 |
| Rectal haemorrhage | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Dry mouth | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| General disorders | ||||||
| Feeling abnormal | 2/14 (14.3%) | 2 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Withdrawal syndrome | 2/14 (14.3%) | 2 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Feeling of body temperature change | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Gait disturbance | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Infections and infestations | ||||||
| Herpes simplex | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Nasopharyngitis | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Oral herpes | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Urinary tract infection | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 3/14 (21.4%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Muscle spasms | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Pain in extremity | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Nervous system disorders | ||||||
| Headache | 7/14 (50%) | 10 | 2/14 (14.3%) | 2 | 3/14 (21.4%) | 3 |
| Dizziness | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 9/14 (64.3%) | 10 |
| Dysarthria | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Memory impairment | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 6/14 (42.9%) | 6 |
| Amnesia | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Balance disorder | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Coordination abnormal | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Depressed level of consciousness | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Dysgeusia | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Presyncope | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Psychomotor hyperactivity | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Sedation | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 11/14 (78.6%) | 11 |
| Tremor | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 2/14 (14.3%) | 2 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Sleep disorder | 2/14 (14.3%) | 2 | 0/14 (0%) | 0 | 3/14 (21.4%) | 3 |
| Behaviour disorder | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Confusional state | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Flat affect | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Panic attack | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Suicide threat | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Abnormal behaviour | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Abnormal dreams | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 3/14 (21.4%) | 3 |
| Affect lability | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Affective disorder | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Attention deficit/hyperactivity disorder | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 6/14 (42.9%) | 6 |
| Communication disorder | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Depressed mood | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Disorientation | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Euphoric mood | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Hallucination | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Insomnia | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Irritability | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Mood swings | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 2/14 (14.3%) | 2 |
| Renal and urinary disorders | ||||||
| Urinary incontinence | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Reproductive system and breast disorders | ||||||
| Dysmenorrhoea | 3/14 (21.4%) | 3 | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 |
| Vaginal haemorrhage | 2/14 (14.3%) | 2 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Epistaxis | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Oropharyngeal pain | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Hiccups | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 4/14 (28.6%) | 6 |
| Skin and subcutaneous tissue disorders | ||||||
| Dry skin | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Pruritus | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Rash | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 2 |
| Skin irritation | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Vascular disorders | ||||||
| Flushing | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 |
Limitations/Caveats
The study was terminated on 22 May 2020 because the program developing padsevonil in focal-onset seizures was stopped.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | UCB |
|---|---|
| Organization | Cares |
| Phone | +1844 599 ext 2273 |
| UCBCares@ucb.com |
Responsible Party:
UCB Biopharma SRL
ClinicalTrials.gov Identifier:
NCT04131517
Other Study ID Numbers:
- UP0035
- 2019-002194-54
First Posted:
Oct 18, 2019
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021