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Trial record 1 of 1 for:    NCT03739840
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A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy (DUET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739840
Recruitment Status : Terminated (Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure)
First Posted : November 14, 2018
Results First Posted : October 25, 2021
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Drug-Resistant Epilepsy
Focal-Onset Seizures
Interventions Drug: Padsevonil
Drug: Placebo
Enrollment 232
Recruitment Details The study started to enroll participants in March 2019 and concluded in September 2020.
Pre-assignment Details

The study included: a 4-week Baseline Period, a 16-week Treatment Period, a 4-week Taper Period (for participants who discontinued or choose not to enroll in the open-label extension study) and a Safety Follow-up Period. Participants continuing to the OLE study had a 3-week Conversion Period.

The Participant Flow refers to the Randomized Set.

Arm/Group Title Placebo Padsevonil 100 mg BID Padsevonil 200 mg BID Padsevonil 400 mg BID
Hide Arm/Group Description Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19
Period Title: Treatment Period: Wk0-16
Started 56 60 57 59
Completed Titration and Stabilization 54 58 51 54
Completed Maintenance Period 46 44 44 36
Completed 46 44 44 36
Not Completed 10 16 13 23
Reason Not Completed
Adverse Event             2             6             6             12
Lack of Efficacy             0             1             0             3
Protocol Violation             0             0             1             0
Consent Withdrawn             1             3             1             1
Program Termination             3             0             1             1
Sponsor Closed Study- Subject Was Discontinued             1             0             0             0
Sponsors Decision             3             2             1             3
Promotor Decision             0             1             0             0
Per Sponsor Study Closed             0             1             0             0
Premature Program Termination             0             1             0             0
Trial Closed By Sponsor             0             1             0             0
Study Early Closure             0             0             1             0
Premature Study Termination By Sponsor             0             0             1             0
Premature Closure Of The Study             0             0             1             0
Study Has Been Cancelled By The Sponsor             0             0             0             1
Due To Sponsor Instruction             0             0             0             1
Trial Was Closed By Sponsor             0             0             0             1
Period Title: Post-Treatment Period: Wk16-23
Started 46 44 44 36
Started Conversion Period 33 31 29 28
Completed Conversion Period 33 31 29 28
Started Taper and Safety Follow-up 19 18 21 13
Completed Taper and Safety Follow-up 15 16 18 12
Enrolled in EP0093 27 26 23 23
Completed 42 42 41 35
Not Completed 4 2 3 1
Reason Not Completed
Adverse Event             3             0             0             0
Consent Withdrawn             0             0             0             1
Sponsor Decision To Terminate The Study             1             0             0             0
Sponsor's Decision             0             1             0             0
Sponsor Closed Study- Subject Was Discontinued             0             1             0             0
Sponsor Decision + Subject Refusal             0             0             1             0
Early Study Closure             0             0             1             0
Trial Closed By Sponsor Decision             0             0             1             0
Arm/Group Title Placebo Padsevonil 100 mg BID Padsevonil 200 mg BID Padsevonil 400 mg BID Total Title
Hide Arm/Group Description Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19 [Not Specified]
Overall Number of Baseline Participants 56 60 57 59 232
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set (RS) consisted of all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 60 participants 57 participants 59 participants 232 participants
<=18 years
1
   1.8%
0
   0.0%
4
   7.0%
0
   0.0%
5
   2.2%
Between 18 and 65 years
52
  92.9%
57
  95.0%
48
  84.2%
56
  94.9%
213
  91.8%
>=65 years
3
   5.4%
3
   5.0%
5
   8.8%
3
   5.1%
14
   6.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 60 participants 57 participants 59 participants 232 participants
41.9  (13.6) 40.7  (13.0) 39.5  (14.3) 39.7  (13.6) 40.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 60 participants 57 participants 59 participants 232 participants
Female
34
  60.7%
34
  56.7%
29
  50.9%
34
  57.6%
131
  56.5%
Male
22
  39.3%
26
  43.3%
28
  49.1%
25
  42.4%
101
  43.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 60 participants 57 participants 59 participants 232 participants
American Indian or Alaska Native
1
   1.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Asian
5
   8.9%
5
   8.3%
7
  12.3%
7
  11.9%
24
  10.3%
Black
0
   0.0%
1
   1.7%
1
   1.8%
1
   1.7%
3
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   3.3%
0
   0.0%
0
   0.0%
2
   0.9%
White
49
  87.5%
50
  83.3%
49
  86.0%
51
  86.4%
199
  85.8%
Other/mixed
1
   1.8%
2
   3.3%
0
   0.0%
0
   0.0%
3
   1.3%
1.Primary Outcome
Title Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
Hide Description During the study, participants kept diaries to record daily seizure activity. Seizure frequency refers to 28-day adjusted frequency. Seizure frequency was based on investigator assessment of participants' reports of daily seizure type and frequency. Observable focal-onset seizures refer to Type IA1, IB, and IC (ILAE Classification of Epileptic Seizures, 1981). Based on ANCOVA on change in log-transformed seizure frequency from Baseline, with treatment group as the main factor, Baseline log-transformed seizure frequency as a continuous covariate, Baseline SV2A use (Yes or No) and Region (Europe, non-Europe) as categorical factors.
Time Frame From Baseline over the 12 Week Maintenance Period (up to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Placebo (FAS) Padsevonil 100 mg BID (FAS) Padsevonil 200 mg BID (FAS) Padsevonil 400 mg BID (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Overall Number of Participants Analyzed 54 59 56 56
Least Squares Mean (95% Confidence Interval)
Unit of Measure: log e seizures per 28 days
-0.41
(-0.6133 to -0.2025)
-0.35
(-0.54906 to -0.15705)
-0.47
(-0.67559 to -0.27382)
-0.47
(-0.67267 to -0.27361)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 100 mg BID (FAS)
Comments Percent reduction over placebo was calculated as 100*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.687
Comments Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-38.1 to 19.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 200 mg BID (FAS)
Comments Percent reduction over placebo was calculated as 100*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.687
Comments Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
-22.7 to 28.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 400 mg BID (FAS)
Comments Percent reduction over placebo was calculated as 100*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.687
Comments Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-22.9 to 28.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.
Time Frame From Baseline until Safety Follow-Up (up to Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.
Arm/Group Title Placebo (SS) Padsevonil 100 mg BID (SS) Padsevonil 200 mg BID (SS) Padsevonil 400 mg BID (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Overall Number of Participants Analyzed 55 60 57 59
Measure Type: Number
Unit of Measure: percentage of participants
69.1 83.3 78.9 84.7
3.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
Hide Description An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.
Time Frame From Baseline until Safety Follow-Up (up to Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.
Arm/Group Title Placebo (SS) Padsevonil 100 mg BID (SS) Padsevonil 200 mg BID (SS) Padsevonil 400 mg BID (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Overall Number of Participants Analyzed 55 60 57 59
Measure Type: Number
Unit of Measure: percentage of participants
7.3 10.0 10.5 20.3
4.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Hide Description A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is as infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.
Time Frame From Baseline until Safety Follow-Up (up to Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.
Arm/Group Title Placebo (SS) Padsevonil 100 mg BID (SS) Padsevonil 200 mg BID (SS) Padsevonil 400 mg BID (SS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.
Overall Number of Participants Analyzed 55 60 57 59
Measure Type: Number
Unit of Measure: percentage of participants
9.1 3.3 1.8 10.2
5.Secondary Outcome
Title 75% Responder Rate From Baseline Over the 12-week Maintenance Period
Hide Description The 75 % responder rate, where a responder was a participant experiencing a ≥75 % reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period.
Time Frame From Baseline over the 12 Week Maintenance Period (up to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Placebo (FAS) Padsevonil 100 mg BID (FAS) Padsevonil 200 mg BID (FAS) Padsevonil 400 mg BID (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Overall Number of Participants Analyzed 54 59 56 56
Measure Type: Number
Unit of Measure: percentage of participants
13.0 15.3 12.5 14.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 100 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.803
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.39 to 3.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 200 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.772
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.27 to 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 400 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.989
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.33 to 3.08
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 50% Responder Rate From Baseline Over the 12-week Maintenance Period
Hide Description The 50% responder rate, where a responder was a participant experiencing a ≥50% reduction in observable focal-onset seizure frequency from Baseline, over the 12-week Maintenance Period.
Time Frame From Baseline over the 12 Week Maintenance Period (up to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Placebo (FAS) Padsevonil 100 mg BID (FAS) Padsevonil 200 mg BID (FAS) Padsevonil 400 mg BID (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Overall Number of Participants Analyzed 54 59 56 56
Measure Type: Number
Unit of Measure: percentage of participants
27.8 35.6 33.9 42.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 100 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.425
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
0.61 to 3.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 200 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.625
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.53 to 2.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 400 mg BID (FAS)
Comments PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.125
Comments Nominal p-values were not adjusted for multiplicity.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
0.84 to 4.34
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
Hide Description During the study, participants kept diaries to record daily seizure activity. The percentage of participants who experienced a 50 % or greater reduction in seizure frequency per 28 days relative to Baseline (responders) were assessed.
Time Frame From Baseline over the 12 Week Maintenance Period (up to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.
Arm/Group Title Placebo (FAS) Padsevonil 100 mg BID (FAS) Padsevonil 200 mg BID (FAS) Padsevonil 400 mg BID (FAS)
Hide Arm/Group Description:
Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).
Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Overall Number of Participants Analyzed 54 59 56 56
Mean (Standard Deviation)
Unit of Measure: percent change
22.34  (44.56) 11.72  (81.52) 30.29  (39.58) 22.41  (62.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 100 mg BID (FAS)
Comments Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.737
Comments Nominal p-values were not adjusted for multiplicity.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
-17.08 to 20.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 200 mg BID (FAS)
Comments Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.458
Comments Nominal p-values were not adjusted for multiplicity.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 6.17
Confidence Interval (2-Sided) 95%
-10.00 to 21.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (FAS), Padsevonil 400 mg BID (FAS)
Comments Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.341
Comments Nominal p-values were not adjusted for multiplicity.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 9.31
Confidence Interval (2-Sided) 95%
-10.92 to 28.21
Estimation Comments [Not Specified]
Time Frame TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23)
Adverse Event Reporting Description TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
 
Arm/Group Title Placebo Treatment Period (SS) Padsevonil 100 mg BID Treatment Period (SS) Padsevonil 200 mg BID Treatment Period (SS) Padsevonil 400 mg BID Treatment Period (SS) Placebo Conversion Period (SS) Padsevonil 100 mg BID Conversion Period (SS) Padsevonil 200 mg BID Conversion Period (SS) Padsevonil 400 mg BID Conversion Period (SS) Placebo Taper and SFU Period (SS) Padsevonil 100 mg BID Taper and SFU Period (SS) Padsevonil 200 mg BID Taper and SFU Period (SS) Padsevonil 400 mg BID Taper and SFU Period (SS)
Hide Arm/Group Description Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS). Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS. Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS. Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS. A 3-Week Conversion Period was required for study participants who chose to enroll in the open-label extension (OLE) study at the end of the 12-Week Maintenance Period. Participants initially randomized to placebo progressively received padsevonil in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the Safety Set (SS). A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 100 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS. A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 200 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS. A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 400 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS. A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to placebo group received 5-6 placebo tablets to maintain the blinding and have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the Safety Set (SS). A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 100 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS. A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 200 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS. A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 400 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
All-Cause Mortality
Placebo Treatment Period (SS) Padsevonil 100 mg BID Treatment Period (SS) Padsevonil 200 mg BID Treatment Period (SS) Padsevonil 400 mg BID Treatment Period (SS) Placebo Conversion Period (SS) Padsevonil 100 mg BID Conversion Period (SS) Padsevonil 200 mg BID Conversion Period (SS) Padsevonil 400 mg BID Conversion Period (SS) Placebo Taper and SFU Period (SS) Padsevonil 100 mg BID Taper and SFU Period (SS) Padsevonil 200 mg BID Taper and SFU Period (SS) Padsevonil 400 mg BID Taper and SFU Period (SS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/60 (0.00%)      0/57 (0.00%)      0/59 (0.00%)      0/33 (0.00%)      0/31 (0.00%)      0/29 (0.00%)      0/28 (0.00%)      0/27 (0.00%)      0/30 (0.00%)      0/31 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Placebo Treatment Period (SS) Padsevonil 100 mg BID Treatment Period (SS) Padsevonil 200 mg BID Treatment Period (SS) Padsevonil 400 mg BID Treatment Period (SS) Placebo Conversion Period (SS) Padsevonil 100 mg BID Conversion Period (SS) Padsevonil 200 mg BID Conversion Period (SS) Padsevonil 400 mg BID Conversion Period (SS) Placebo Taper and SFU Period (SS) Padsevonil 100 mg BID Taper and SFU Period (SS) Padsevonil 200 mg BID Taper and SFU Period (SS) Padsevonil 400 mg BID Taper and SFU Period (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/55 (5.45%)      0/60 (0.00%)      1/57 (1.75%)      5/59 (8.47%)      1/33 (3.03%)      0/31 (0.00%)      0/29 (0.00%)      0/28 (0.00%)      1/27 (3.70%)      2/30 (6.67%)      0/31 (0.00%)      1/32 (3.13%)    
Injury, poisoning and procedural complications                         
Radius fracture * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Skin laceration * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Subdural haematoma * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Wrist fracture * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Contusion * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Humerus fracture * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Rib fracture * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Metabolism and nutrition disorders                         
Hyponatraemia * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Muscular weakness * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders                         
Epilepsy * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 1/57 (1.75%)  1 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Focal dyscognitive seizures * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Seizure * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0
Status epilepticus * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1
Psychiatric disorders                         
Aggression * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Emotional disorder * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Suicidal ideation * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Pneumothorax * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0
Surgical and medical procedures                         
Abortion induced * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Treatment Period (SS) Padsevonil 100 mg BID Treatment Period (SS) Padsevonil 200 mg BID Treatment Period (SS) Padsevonil 400 mg BID Treatment Period (SS) Placebo Conversion Period (SS) Padsevonil 100 mg BID Conversion Period (SS) Padsevonil 200 mg BID Conversion Period (SS) Padsevonil 400 mg BID Conversion Period (SS) Placebo Taper and SFU Period (SS) Padsevonil 100 mg BID Taper and SFU Period (SS) Padsevonil 200 mg BID Taper and SFU Period (SS) Padsevonil 400 mg BID Taper and SFU Period (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/55 (45.45%)      37/60 (61.67%)      40/57 (70.18%)      41/59 (69.49%)      7/33 (21.21%)      0/31 (0.00%)      1/29 (3.45%)      1/28 (3.57%)      2/27 (7.41%)      6/30 (20.00%)      4/31 (12.90%)      2/32 (6.25%)    
Gastrointestinal disorders                         
Nausea * 1  3/55 (5.45%)  5 1/60 (1.67%)  1 3/57 (5.26%)  4 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Diarrhoea * 1  3/55 (5.45%)  4 1/60 (1.67%)  1 0/57 (0.00%)  0 2/59 (3.39%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
General disorders                         
Fatigue * 1  4/55 (7.27%)  4 5/60 (8.33%)  5 7/57 (12.28%)  7 14/59 (23.73%)  15 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Asthenia * 1  2/55 (3.64%)  2 6/60 (10.00%)  6 3/57 (5.26%)  4 2/59 (3.39%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0
Gait disturbance * 1  0/55 (0.00%)  0 2/60 (3.33%)  2 2/57 (3.51%)  3 4/59 (6.78%)  4 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Infections and infestations                         
Nasopharyngitis * 1  4/55 (7.27%)  4 1/60 (1.67%)  1 4/57 (7.02%)  4 1/59 (1.69%)  1 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Injury, poisoning and procedural complications                         
Fall * 1  0/55 (0.00%)  0 0/60 (0.00%)  0 3/57 (5.26%)  4 2/59 (3.39%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0 1/27 (3.70%)  1 0/30 (0.00%)  0 1/31 (3.23%)  1 1/32 (3.13%)  1
Contusion * 1  3/55 (5.45%)  4 1/60 (1.67%)  1 2/57 (3.51%)  2 1/59 (1.69%)  1 1/33 (3.03%)  1 0/31 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0 0/27 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0
Metabolism and nutrition disorders                         
Decreased appetite * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 3/57 (5.26%)  3 1/59 (1.69%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders                         
Somnolence * 1  2/55 (3.64%)  2 10/60 (16.67%)  11 19/57 (33.33%)  22 20/59 (33.90%)  23 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0
Dizziness * 1  4/55 (7.27%)  5 14/60 (23.33%)  14 10/57 (17.54%)  13 18/59 (30.51%)  19 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 1/27 (3.70%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Headache * 1  8/55 (14.55%)  13 10/60 (16.67%)  22 9/57 (15.79%)  16 5/59 (8.47%)  8 0/33 (0.00%)  0 0/31 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0 4/30 (13.33%)  12 2/31 (6.45%)  2 1/32 (3.13%)  1
Memory impairment * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 3/57 (5.26%)  3 6/59 (10.17%)  6 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Tremor * 1  1/55 (1.82%)  1 3/60 (5.00%)  5 0/57 (0.00%)  0 4/59 (6.78%)  4 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  1 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Disturbance in attention * 1  1/55 (1.82%)  1 1/60 (1.67%)  1 5/57 (8.77%)  5 2/59 (3.39%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Balance disorder * 1  0/55 (0.00%)  0 1/60 (1.67%)  1 3/57 (5.26%)  3 2/59 (3.39%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0
Dysarthria * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 5/59 (8.47%)  5 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Seizure * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 4/57 (7.02%)  5 0/59 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Psychiatric disorders                         
Insomnia * 1  0/55 (0.00%)  0 1/60 (1.67%)  1 5/57 (8.77%)  6 4/59 (6.78%)  4 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Irritability * 1  3/55 (5.45%)  3 4/60 (6.67%)  4 3/57 (5.26%)  3 3/59 (5.08%)  3 1/33 (3.03%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Anxiety * 1  1/55 (1.82%)  1 0/60 (0.00%)  0 1/57 (1.75%)  2 3/59 (5.08%)  3 0/33 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
Vascular disorders                         
Hypotension * 1  0/55 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 2/33 (6.06%)  2 0/31 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA22.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03739840    
Other Study ID Numbers: EP0092
2018-002303-33 ( EudraCT Number )
First Submitted: November 9, 2018
First Posted: November 14, 2018
Results First Submitted: September 24, 2021
Results First Posted: October 25, 2021
Last Update Posted: December 21, 2022