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TerminatedNCT03739840DUETUpdated Dec 21, 2022Results posted

A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

A Phase 3 interventional study of Padsevonil and Placebo in Drug-Resistant Epilepsy and Focal-Onset Seizures, sponsored by UCB Biopharma SRL. Terminated at 141 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment

Why this study was terminated
Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Phase
Phase 3
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

02

Conditions studied

  • Drug-Resistant Epilepsy
  • Focal-Onset Seizures

Keywords

  • Epilepsy
  • Padsevonil
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 232 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
  • Subject has failed to achieve seizure control with >=4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
  • Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
  • Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments

Exclusion criteria

Exclusion Criteria:

  • Subject has a history of or signs of generalized or combined generalized and focal epilepsy
  • Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
  • Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
  • Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
  • Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
  • Subject has been taking vigabatrin less than 2 years at study entry
  • Subject has been taking felbamate for less than 12 months
  • Subject taking retigabine for less than 4 years
  • Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) \<3 times per week for emergencies
  • Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    Padsevonil dosing regimen 1

    Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

    Drug: Padsevonil · Drug: Placebo

  • Experimental
    Padsevonil dosing regimen 2

    Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

    Drug: Padsevonil · Drug: Placebo

  • Experimental
    Padsevonil dosing regimen 3

    Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

    Drug: Padsevonil · Drug: Placebo

  • Placebo comparator
    Placebo

    Subjects randomized to the placebo group will receive a combination of several placebo tablets to maintain the blinding.

    Drug: Placebo

Interventions

  • DrugPadsevonil

    Padsevonil in different dosages.

  • DrugPlacebo

    Placebo will be provided matching padsevonil.

06

What researchers measure

Primary outcomes

  1. Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period

    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)

  2. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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)

  3. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal

    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)

  4. Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

    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)

Secondary outcomes

  1. 75% Responder Rate From Baseline Over the 12-week Maintenance Period

    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)

  2. 50% Responder Rate From Baseline Over the 12-week Maintenance Period

    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)

  3. Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period

    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)

07

Results

Posted Oct 25, 2021

Participant flow

The study started to enroll participants in March 2019 and concluded in September 2020.

Treatment Period: Wk0-16
Participant flow — Treatment Period: Wk0-16
MilestonePlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BID
Started56605759
Completed titration and stabilization54585154
Completed maintenance period46444436
Completed46444436
Not completed10161323
Withdrew: Adverse event26612
Withdrew: Lack of efficacy0103
Withdrew: Protocol violation0010
Withdrew: Consent withdrawn1311
Withdrew: Program termination3011
Withdrew: Sponsor closed study- subject was discontinued1000
Withdrew: Sponsors decision3213
Withdrew: Promotor decision0100
Withdrew: Per sponsor study closed0100
Withdrew: Premature program termination0100
Withdrew: Trial closed by sponsor0100
Withdrew: Study early closure0010
Withdrew: Premature study termination by sponsor0010
Withdrew: Premature closure of the study0010
Withdrew: Study has been cancelled by the sponsor0001
Withdrew: Due to sponsor instruction0001
Withdrew: Trial was closed by sponsor0001
Post-Treatment Period: Wk16-23
Participant flow — Post-Treatment Period: Wk16-23
MilestonePlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BID
Started46444436
Started conversion period33312928
Completed conversion period33312928
Started taper and safety follow-up19182113
Completed taper and safety follow-up15161812
Enrolled in ep009327262323
Completed42424135
Not completed4231
Withdrew: Adverse event3000
Withdrew: Consent withdrawn0001
Withdrew: Sponsor decision to terminate the study1000
Withdrew: Sponsor's decision0100
Withdrew: Sponsor closed study- subject was discontinued0100
Withdrew: Sponsor decision + subject refusal0010
Withdrew: Early study closure0010
Withdrew: Trial closed by sponsor decision0010

Outcome measures

PrimaryChange in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period

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)
Reported as:
Least squares mean · log e seizures per 28 days
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
log e seizures per 28 daysPlacebo (FAS)Padsevonil 100 mg BID (FAS)Padsevonil 200 mg BID (FAS)Padsevonil 400 mg BID (FAS)
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period-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)
Statistical analysis
  • Placebo (FAS) vs Padsevonil 100 mg BID (FAS) · ANCOVA · p = =0.687 (Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: -5.6 · 95% CI -38.1 to 19.2
  • Placebo (FAS) vs Padsevonil 200 mg BID (FAS) · ANCOVA · p = =0.687 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 6.5 · 95% CI -22.7 to 28.7
  • Placebo (FAS) vs Padsevonil 400 mg BID (FAS) · ANCOVA · p = =0.687 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 6.3 · 95% CI -22.9 to 28.6
PrimaryPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

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)
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
percentage of participantsPlacebo (SS)Padsevonil 100 mg BID (SS)Padsevonil 200 mg BID (SS)Padsevonil 400 mg BID (SS)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)69.183.378.984.7
PrimaryPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal

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)
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
percentage of participantsPlacebo (SS)Padsevonil 100 mg BID (SS)Padsevonil 200 mg BID (SS)Padsevonil 400 mg BID (SS)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal7.310.010.520.3
PrimaryPercentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

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)
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
percentage of participantsPlacebo (SS)Padsevonil 100 mg BID (SS)Padsevonil 200 mg BID (SS)Padsevonil 400 mg BID (SS)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)9.13.31.810.2
Secondary75% Responder Rate From Baseline Over the 12-week Maintenance Period

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)
Reported as:
Number · percentage of participants
75% Responder Rate From Baseline Over the 12-week Maintenance Period
percentage of participantsPlacebo (FAS)Padsevonil 100 mg BID (FAS)Padsevonil 200 mg BID (FAS)Padsevonil 400 mg BID (FAS)
75% Responder Rate From Baseline Over the 12-week Maintenance Period13.015.312.514.3
Statistical analysis
  • Placebo (FAS) vs Padsevonil 100 mg BID (FAS) · Regression, Logistic · p = =0.803 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.15 · 95% CI 0.39 to 3.38
  • Placebo (FAS) vs Padsevonil 200 mg BID (FAS) · Regression, Logistic · p = =0.772 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 0.84 · 95% CI 0.27 to 2.65
  • Placebo (FAS) vs Padsevonil 400 mg BID (FAS) · Regression, Logistic · p = =0.989 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.01 · 95% CI 0.33 to 3.08
Secondary50% Responder Rate From Baseline Over the 12-week Maintenance Period

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)
Reported as:
Number · percentage of participants
50% Responder Rate From Baseline Over the 12-week Maintenance Period
percentage of participantsPlacebo (FAS)Padsevonil 100 mg BID (FAS)Padsevonil 200 mg BID (FAS)Padsevonil 400 mg BID (FAS)
50% Responder Rate From Baseline Over the 12-week Maintenance Period27.835.633.942.9
Statistical analysis
  • Placebo (FAS) vs Padsevonil 100 mg BID (FAS) · Regression, Logistic · p = =0.425 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.40 · 95% CI 0.61 to 3.18
  • Placebo (FAS) vs Padsevonil 200 mg BID (FAS) · Regression, Logistic · p = =0.625 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.23 · 95% CI 0.53 to 2.85
  • Placebo (FAS) vs Padsevonil 400 mg BID (FAS) · Regression, Logistic · p = =0.125 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.90 · 95% CI 0.84 to 4.34
SecondaryPercent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period

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)
Reported as:
Mean · percent change
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
percent changePlacebo (FAS)Padsevonil 100 mg BID (FAS)Padsevonil 200 mg BID (FAS)Padsevonil 400 mg BID (FAS)
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period22.34 ± 44.5611.72 ± 81.5230.29 ± 39.5822.41 ± 62.80
Statistical analysis
  • Placebo (FAS) vs Padsevonil 100 mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.737 (Nominal p-values were not adjusted for multiplicity.) · Median difference (final values): 3.25 · 95% CI -17.08 to 20.36
  • Placebo (FAS) vs Padsevonil 200 mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.458 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 6.17 · 95% CI -10.00 to 21.91
  • Placebo (FAS) vs Padsevonil 400 mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.341 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 9.31 · 95% CI -10.92 to 28.21

Adverse events

Collected over TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Treatment Period (SS)0/55 (0%)3/55 (5.5%)25/55 (45.5%)
Padsevonil 100 mg BID Treatment Period (SS)0/60 (0%)0/60 (0%)37/60 (61.7%)
Padsevonil 200 mg BID Treatment Period (SS)0/57 (0%)1/57 (1.8%)40/57 (70.2%)
Padsevonil 400 mg BID Treatment Period (SS)0/59 (0%)5/59 (8.5%)41/59 (69.5%)
Placebo Conversion Period (SS)0/33 (0%)1/33 (3%)7/33 (21.2%)
Padsevonil 100 mg BID Conversion Period (SS)0/31 (0%)0/31 (0%)0/31 (0%)
Padsevonil 200 mg BID Conversion Period (SS)0/29 (0%)0/29 (0%)1/29 (3.4%)
Padsevonil 400 mg BID Conversion Period (SS)0/28 (0%)0/28 (0%)1/28 (3.6%)
Placebo Taper and SFU Period (SS)0/27 (0%)1/27 (3.7%)2/27 (7.4%)
Padsevonil 100 mg BID Taper and SFU Period (SS)0/30 (0%)2/30 (6.7%)6/30 (20%)
Padsevonil 200 mg BID Taper and SFU Period (SS)0/31 (0%)0/31 (0%)4/31 (12.9%)
Padsevonil 400 mg BID Taper and SFU Period (SS)0/32 (0%)1/32 (3.1%)2/32 (6.3%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventPlacebo 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)
Emotional disorderPsychiatric disorders0/550/600/570/590/330/310/290/281/270/300/310/32
Suicidal ideationPsychiatric disorders0/550/600/570/590/330/310/290/281/270/300/310/32
SeizureNervous system disorders0/550/600/570/590/330/310/290/280/271/300/310/32
PneumothoraxRespiratory, thoracic and mediastinal disorders0/550/600/570/590/330/310/290/280/271/300/310/32
Status epilepticusNervous system disorders0/550/600/570/590/330/310/290/280/270/300/311/32
ContusionInjury, poisoning and procedural complications0/550/600/570/591/330/310/290/280/270/300/310/32
Humerus fractureInjury, poisoning and procedural complications0/550/600/570/591/330/310/290/280/270/300/310/32
Rib fractureInjury, poisoning and procedural complications0/550/600/570/591/330/310/290/280/270/300/310/32
Skin lacerationInjury, poisoning and procedural complications1/550/600/570/590/330/310/290/280/270/300/310/32
Subdural haematomaInjury, poisoning and procedural complications1/550/600/570/590/330/310/290/280/270/300/310/32
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlacebo 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)
SomnolenceNervous system disorders2/5510/6019/5720/591/330/310/290/280/271/300/310/32
DizzinessNervous system disorders4/5514/6010/5718/590/330/310/290/281/270/300/310/32
FatigueGeneral disorders4/555/607/5714/591/330/310/290/280/270/300/310/32
HeadacheNervous system disorders8/5510/609/575/590/330/310/280/270/274/302/311/32
Memory impairmentNervous system disorders1/550/603/576/590/330/310/290/280/270/300/310/32
AstheniaGeneral disorders2/556/603/572/590/330/310/290/280/270/301/310/32
Disturbance in attentionNervous system disorders1/551/605/572/590/330/310/290/280/270/300/310/32
InsomniaPsychiatric disorders0/551/605/574/590/330/310/290/280/270/300/310/32
DysarthriaNervous system disorders1/550/600/575/590/330/310/290/280/270/300/310/32
NasopharyngitisInfections and infestations4/551/604/571/591/330/310/290/280/270/300/310/32

Baseline characteristics

Baseline Characteristics refer to the Randomized Set (RS) consisted of all participants randomized into the study.

Age, Categorical
Age, Categorical(Participants)PlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BIDTotal Title
<=18 years10405
Between 18 and 65 years52574856213
>=65 years335314
Age, Continuous
Age, Continuous(years)PlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BIDTotal Title
Mean41.9 ± 13.640.7 ± 13.039.5 ± 14.339.7 ± 13.640.4 ± 13.6
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BIDTotal Title
Female34342934131
Male22262825101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboPadsevonil 100 mg BIDPadsevonil 200 mg BIDPadsevonil 400 mg BIDTotal Title
American Indian or Alaska Native10001
Asian557724
Black01113
Native Hawaiian or Other Pacific Islander02002
White49504951199
Other/mixed12003
08

Study locations

141 sites
  • Ep0092 839
    Chandler, Arizona 85226, United States
  • Ep0092 881
    Tucson, Arizona 85724, United States
  • Ep0092 633
    Carlsbad, California 92011, United States
  • Ep0092 629
    Orange, California 92868, United States
  • Ep0092 845
    Washington, District of Columbia 20037, United States
  • Ep0092 892
    Bradenton, Florida 34209, United States
  • Ep0092 640
    Hialeah, Florida 33016, United States
  • Ep0092 641
    Jacksonville, Florida 32209, United States
  • Ep0092 823
    Orlando, Florida 32806, United States
  • Ep0092 803
    Honolulu, Hawaii 96817, United States
  • Ep0092 637
    Urbana, Illinois 61801, United States
  • Ep0092 880
    Anderson, Indiana 46011, United States
  • Ep0092 638
    Fort Wayne, Indiana 46804, United States
  • Ep0092 630
    Ames, Iowa 50010, United States
  • Ep0092 707
    Lexington, Kentucky 40536, United States
  • Ep0092 822
    Baltimore, Maryland 21287, United States
  • Ep0092 818
    Bethesda, Maryland 20817, United States
  • Ep0092 889
    Boston, Massachusetts 02215, United States
  • Ep0092 645
    Golden Valley, Minnesota 55422, United States
  • Ep0092 644
    Minneapolis, Minnesota 55416, United States
  • Ep0092 895
    Bronx, New York 10467, United States
  • Ep0092 878
    Brooklyn, New York 11203, United States
  • Ep0092 876
    New York, New York 10075, United States
  • Ep0092 893
    Syracuse, New York 13210, United States
  • Ep0092 890
    Chapel Hill, North Carolina 27599, United States
  • Ep0092 884
    Charlotte, North Carolina 28204, United States
  • Ep0092 642
    Columbus, Ohio 43210, United States
  • Ep0092 647
    Oklahoma City, Oklahoma 73106, United States
  • Ep0092 882
    Portland, Oregon 97225, United States
  • Ep0092 802
    Philadelphia, Pennsylvania 19107, United States
  • Ep0092 829
    Charlottesville, Virginia 22903, United States
  • Ep0092 639
    Renton, Washington 98055, United States
  • Ep0092 855
    Box Hill, Australia
  • Ep0092 861
    Camperdown, Australia
  • Ep0092 850
    Fitzroy, Australia
  • Ep0092 853
    Heidelberg, Australia
  • Ep0092 852
    Melbourne, Australia
  • Ep0092 109
    Brussels, Belgium
  • Ep0092 107
    Ottignies, Belgium
  • Ep0092 080
    Bihać, Bosnia and Herzegovina
  • Ep0092 077
    Mostar, Bosnia and Herzegovina
  • Ep0092 075
    Sarajevo, Bosnia and Herzegovina
  • Ep0092 082
    Tuzla, Bosnia and Herzegovina
  • Ep0092 150
    Blagoevgrad, Bulgaria
  • Ep0092 151
    Pleven, Bulgaria
  • Ep0092 156
    Pleven, Bulgaria
  • Ep0092 154
    Sofia, Bulgaria
  • Ep0092 125
    Zagreb, Croatia
  • Ep0092 126
    Zagreb, Croatia
  • Ep0092 127
    Zagreb, Croatia
  • Ep0092 128
    Zagreb, Croatia
  • Ep0092 254
    Brno, Czechia
  • Ep0092 258
    Ostrava, Czechia
  • Ep0092 250
    Praha 5, Czechia
  • Ep0092 251
    Praha 6, Czechia
  • Ep0092 016
    Aarhus, Denmark
  • Ep0092 015
    Odense, Denmark
  • Ep0092 276
    Tallinn, Estonia
  • Ep0092 277
    Tallinn, Estonia
  • Ep0092 275
    Tartu, Estonia
  • Ep0092 027
    Tampere, Finland
  • Ep0092 312
    Lyon, France
  • Ep0092 310
    Paris, France
  • Ep0092 301
    Strasbourg, France
  • Ep0092 365
    Berlin, Germany
  • Ep0092 362
    Bernau, Germany
  • Ep0092 363
    Bielefeld, Germany
  • Ep0092 350
    Frankfurt, Germany
  • Ep0092 368
    Jena, Germany
  • Ep0092 357
    Leipzig, Germany
  • Ep0092 376
    Regensburg, Germany
  • Ep0092 425
    Ioánnina, Greece
  • Ep0092 426
    Thessaloníki, Greece
  • Ep0092 427
    Thessaloníki, Greece
  • Ep0092 428
    Thessaloníki, Greece
  • Ep0092 403
    Budapest, Hungary
  • Ep0092 405
    Debrecen, Hungary
  • Ep0092 404
    Pécs, Hungary
  • Ep0092 035
    Cork, Ireland
  • Ep0092 036
    Dublin, Ireland
  • Ep0092 452
    Milano, Italy
  • Ep0092 526
    Asahikawa, Japan
  • Ep0092 501
    Asaka, Japan
  • Ep0092 521
    Bunkyō-Ku, Japan
  • Ep0092 525
    Bunkyō-Ku, Japan
  • Ep0092 504
    Hamamatsu, Japan
  • Ep0092 505
    Hiroshima, Japan
  • Ep0092 513
    Hōfu, Japan
  • Ep0092 507
    Itami, Japan
  • Ep0092 531
    Izumi, Japan
  • Ep0092 539
    Kumamoto, Japan
  • Ep0092 533
    Kure, Japan
  • Ep0092 514
    Kyoto, Japan
  • Ep0092 512
    Nagakute, Japan
  • Ep0092 515
    Saitama, Japan
  • Ep0092 508
    Sapporo, Japan
  • Ep0092 527
    Shinagawa-Ku, Japan
  • Ep0092 509
    Shizuoka, Japan
  • Ep0092 529
    Yonago, Japan
  • Ep0092 522
    Ōmura, Japan

Showing the first 100 of 141 sites across 28 countries.

09

References and documents

Publications

  • Rademacher M, Toledo M, Van Paesschen W, Liow KK, Milanov IG, Esch ML, Wang N, MacPherson M, Byrnes WJ, Minh TDC, Webster E, Werhahn KJ. Efficacy and safety of adjunctive padsevonil in adults with drug-resistant focal epilepsy: Results from two double-blind, randomized, placebo-controlled trials. Epilepsia Open. 2022 Dec;7(4):758-770. doi: 10.1002/epi4.12656. Epub 2022 Oct 22. PubMed 36176044 ↗

Study documents

  • Study protocol · Jan 21, 2020
  • Statistical analysis plan · Aug 18, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03739840
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Nov 14, 2018
Start date
Mar 6, 2019
Primary completion
Sep 28, 2020
Completion
Sep 28, 2020
Results posted
Oct 25, 2021
Last update
Dec 21, 2022

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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