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CompletedNCT03373383ARISEUpdated Dec 19, 2023Results posted

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

A Phase 2 interventional study of Padsevonil and Placebo in Drug-resistant Epilepsy and Focal-Onset Seizures, sponsored by UCB Biopharma S.P.R.L.. Completed at 148 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
411
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) 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

Drug Resistant Epilepsy

257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.

This study's enrollment of 411 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.

Browse Drug Resistant Epilepsy studies →

Lead sponsor

UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Browse UCB Biopharma S.P.R.L. studies →All UCB S.A. studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
411 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 · Other: 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 · Other: 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 · Other: Placebo

  • Experimental
    Padsevonil dosing regimen 4

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

    Drug: Padsevonil · Other: Placebo

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • DrugPadsevonil

    Padsevonil in different dosages.

  • OtherPlacebo

    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, 28-day adjusted 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

  2. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study

    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.

    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.

    Time frame: From Baseline until Safety Follow-Up (up to Week 23)

  4. Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study

    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 an 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.

    Time frame: From Baseline until Safety Follow-Up (up to Week 23)

Secondary outcomes

  1. 75 % Responder Rate Over the 12 Week Maintenance Period

    The 75% responder rate, where a responder is a participant experiencing a ≥75% reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period.

    Time frame: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

  2. 50 % Responder Rate 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: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

  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) was assessed.

    Time frame: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

07

Results

Posted Apr 9, 2021

Participant flow

The study started to enroll patients in February 2018 and concluded in January 2020.

Treatment Period: Wk0-16
Participant flow — Treatment Period: Wk0-16
MilestonePlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BID
Started8381838282
Completed titration and stabilization7872716865
Completed maintenance period7066686158
Had taper and safety follow-up61181821
Completed7066686158
Not completed1315152124
Withdrew: Adverse event76111521
Withdrew: Lack of efficacy21000
Withdrew: Protocol violation04210
Withdrew: Lost to follow-up20000
Withdrew: Withdrawal by subject23233
Withdrew: As advised by the sponsor01000
Withdrew: By opinion of investigator00010
Withdrew: Sponsor decision00010
Post-Treatment Period: Wk16-23
Participant flow — Post-Treatment Period: Wk16-23
MilestonePlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BID
Started7066686158
Started conversion period6964665557
Completed conversion period6864665557
Had taper and safety follow-up33361
Enrolled in ep00936763655557
Completed6966686158
Not completed10000
Withdrew: Participant decided not to roll over10000

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, 28-day adjusted 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
Reported as:
Least squares mean · loge seizures per 28 days
Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period
loge seizures per 28 daysPlacebo (FAS)Padsevonil 50mg BID (FAS)Padsevonil 100mg BID (FAS)Padsevonil 200mg BID (FAS)Padsevonil 400mg BID (FAS)
Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period-0.27585 (-0.44311 to -0.10858)-0.46424 (-0.63276 to -0.29573)-0.48804 (-0.65436 to -0.32172)-0.48960 (-0.65734 to -0.32187)-0.40831 (-0.57485 to -0.24177)
Statistical analysis
  • Placebo (FAS) vs Padsevonil 50mg BID (FAS) · ANCOVA · p = =0.102 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 17.2 · 95% CI -3.8 to 33.9
  • Placebo (FAS) vs Padsevonil 100mg BID (FAS) · ANCOVA · p = =0.064 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 19.1 · 95% CI -1.2 to 35.4
  • Placebo (FAS) vs Padsevonil 200mg BID (FAS) · ANCOVA · p = =0.063 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 19.2 · 95% CI -1.2 to 35.5
  • Placebo (FAS) vs Padsevonil 400mg BID (FAS) · ANCOVA · p = =0.248 (Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.) · Percent reduction: 12.4 · 95% CI -9.7 to 30.1
Secondary75 % Responder Rate Over the 12 Week Maintenance Period

The 75% responder rate, where a responder is a participant experiencing a ≥75% reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period.

Time frame:
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
Reported as:
Number · percentage of participants
75 % Responder Rate Over the 12 Week Maintenance Period
percentage of participantsPlacebo (FAS)Padsevonil 50mg BID (FAS)Padsevonil 100mg BID (FAS)Padsevonil 200mg BID (FAS)Padsevonil 400mg BID (FAS)
75 % Responder Rate Over the 12 Week Maintenance Period6.213.812.211.116.0
Statistical analysis
  • Placebo (FAS) vs Padsevonil 50mg BID (FAS) · Regression, Logistic · p = =0.081 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 2.72 · 95% CI 0.88 to 8.39
  • Placebo (FAS) vs Padsevonil 100mg BID (FAS) · Regression, Logistic · p = =0.137 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 2.37 · 95% CI 0.76 to 7.41
  • Placebo (FAS) vs Padsevonil 200mg BID (FAS) · Regression, Logistic · p = =0.192 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 2.16 · 95% CI 0.68 to 6.89
  • Placebo (FAS) vs Padsevonil 400mg BID (FAS) · Regression, Logistic · p = =0.041 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 3.14 · 95% CI 1.05 to 9.42
PrimaryPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study

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.

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) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study
percentage of participantsPlacebo (SS)Padsevonil 50mg BID (SS)Padsevonil 100mg BID (SS)Padsevonil 200mg BID (SS)Padsevonil 400mg BID (SS)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study78.384.080.775.692.6
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.

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 50mg BID (SS)Padsevonil 100mg BID (SS)Padsevonil 200mg BID (SS)Padsevonil 400mg BID (SS)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal8.47.412.018.325.9
PrimaryPercentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study

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 an 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.

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) During the Entire Study
percentage of participantsPlacebo (SS)Padsevonil 50mg BID (SS)Padsevonil 100mg BID (SS)Padsevonil 200mg BID (SS)Padsevonil 400mg BID (SS)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study4.87.44.86.16.2
Secondary50 % Responder Rate 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:
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
Reported as:
Number · percentage of participants
50 % Responder Rate Over the 12 Week Maintenance Period
percentage of participantsPlacebo (FAS)Padsevonil 50mg BID (FAS)Padsevonil 100mg BID (FAS)Padsevonil 200mg BID (FAS)Padsevonil 400mg BID (FAS)
50 % Responder Rate Over the 12 Week Maintenance Period21.033.831.725.932.1
Statistical analysis
  • Placebo (FAS) vs Padsevonil 50mg BID (FAS) · Regression, Logistic · p = =0.045 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 2.09 · 95% CI 1.02 to 4.30
  • Placebo (FAS) vs Padsevonil 100mg BID (FAS) · Regression, Logistic · p = =0.079 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.91 · 95% CI 0.93 to 3.93
  • Placebo (FAS) vs Padsevonil 200mg BID (FAS) · Regression, Logistic · p = =0.338 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.44 · 95% CI 0.68 to 3.02
  • Placebo (FAS) vs Padsevonil 400mg BID (FAS) · Regression, Logistic · p = =0.087 (Nominal p-values were not adjusted for multiplicity.) · Odds ratio (or): 1.88 · 95% CI 0.91 to 3.87
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) was assessed.

Time frame:
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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 50mg BID (FAS)Padsevonil 100mg BID (FAS)Padsevonil 200mg BID (FAS)Padsevonil 400mg BID (FAS)
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period12.49 ± 58.2624.70 ± 46.6225.25 ± 51.7320.79 ± 66.5415.79 ± 67.55
Statistical analysis
  • Placebo (FAS) vs Padsevonil 50mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.316 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 7.40 · 95% CI -6.59 to 21.89
  • Placebo (FAS) vs Padsevonil 100mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.133 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 9.99 · 95% CI -3.15 to 23.26
  • Placebo (FAS) vs Padsevonil 200mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.203 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 8.19 · 95% CI -3.95 to 21.37
  • Placebo (FAS) vs Padsevonil 400mg BID (FAS) · Wilcoxon (Mann-Whitney) · p = =0.784 (Nominal p-values were not adjusted for multiplicity.) · Median difference (net): 2.39 · 95% CI -13.65 to 17.79

Adverse events

Collected over Treatment-emergent AEs were collected from Baseline to 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)0/83 (0%)3/83 (3.6%)45/83 (54.2%)
Padsevonil 50mg BID Treatment Period (SS)0/81 (0%)5/81 (6.2%)54/81 (66.7%)
Padsevonil 100mg BID Treatment Period (SS)0/83 (0%)4/83 (4.8%)60/83 (72.3%)
Padsevonil 200mg BID Treatment Period (SS)0/82 (0%)3/82 (3.7%)53/82 (64.6%)
Padsevonil 400mg BID Treatment Period (SS)0/81 (0%)5/81 (6.2%)65/81 (80.2%)
Placebo Conversion Period (SS)0/69 (0%)0/69 (0%)11/69 (15.9%)
Padsevonil 50mg BID Conversion Period (SS)0/64 (0%)0/64 (0%)18/64 (28.1%)
Padsevonil 100mg BID Conversion Period (SS)0/66 (0%)0/66 (0%)10/66 (15.2%)
Padsevonil 200mg BID Conversion Period (SS)0/55 (0%)2/55 (3.6%)5/55 (9.1%)
Padsevonil 400mg BID Conversion Period (SS)0/57 (0%)0/57 (0%)5/57 (8.8%)
Placebo Taper and SFU Period (SS)0/9 (0%)1/9 (11.1%)3/9 (33.3%)
Padsevonil 50mg BID Taper and SFU Period (SS)0/14 (0%)1/14 (7.1%)3/14 (21.4%)
Padsevonil 100mg BID Taper and SFU Period (SS)0/11 (0%)0/11 (0%)0/11 (0%)
Padsevonil 200mg BID Taper and SFU Period (SS)0/24 (0%)0/24 (0%)3/24 (12.5%)
Padsevonil 400mg BID Taper and SFU Period (SS)0/22 (0%)0/22 (0%)4/22 (18.2%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventPlacebo Treatment Period (SS)Padsevonil 50mg BID Treatment Period (SS)Padsevonil 100mg BID Treatment Period (SS)Padsevonil 200mg BID Treatment Period (SS)Padsevonil 400mg BID Treatment Period (SS)Placebo Conversion Period (SS)Padsevonil 50mg BID Conversion Period (SS)Padsevonil 100mg BID Conversion Period (SS)Padsevonil 200mg BID Conversion Period (SS)Padsevonil 400mg BID Conversion Period (SS)Placebo Taper and SFU Period (SS)Padsevonil 50mg BID Taper and SFU Period (SS)Padsevonil 100mg BID Taper and SFU Period (SS)Padsevonil 200mg BID Taper and SFU Period (SS)Padsevonil 400mg BID Taper and SFU Period (SS)
Acute psychosisPsychiatric disorders0/830/810/830/820/810/690/640/660/550/571/90/140/110/240/22
Head injuryInjury, poisoning and procedural complications0/830/811/830/821/810/690/640/660/550/570/91/140/110/240/22
Status epilepticusNervous system disorders1/831/811/831/821/810/690/640/661/550/570/90/140/110/240/22
DepressionPsychiatric disorders0/830/810/830/820/810/690/640/661/550/570/90/140/110/240/22
Atrial flutterCardiac disorders0/831/810/830/820/810/690/640/660/550/570/90/140/110/240/22
DiverticulitisInfections and infestations0/831/810/830/820/810/690/640/660/550/570/90/140/110/240/22
Altered state of consciousnessNervous system disorders0/830/810/830/821/810/690/640/660/550/570/90/140/110/240/22
EncephalopathyNervous system disorders0/830/810/830/821/810/690/640/660/550/570/90/140/110/240/22
Focal dyscognitive seizuresNervous system disorders0/831/810/830/820/810/690/640/660/550/570/90/140/110/240/22
Partial seizuresNervous system disorders0/831/810/830/820/810/690/640/660/550/570/90/140/110/240/22
Most frequent other events
Showing 10 of 24
Most frequent other events
EventPlacebo Treatment Period (SS)Padsevonil 50mg BID Treatment Period (SS)Padsevonil 100mg BID Treatment Period (SS)Padsevonil 200mg BID Treatment Period (SS)Padsevonil 400mg BID Treatment Period (SS)Placebo Conversion Period (SS)Padsevonil 50mg BID Conversion Period (SS)Padsevonil 100mg BID Conversion Period (SS)Padsevonil 200mg BID Conversion Period (SS)Padsevonil 400mg BID Conversion Period (SS)Placebo Taper and SFU Period (SS)Padsevonil 50mg BID Taper and SFU Period (SS)Padsevonil 100mg BID Taper and SFU Period (SS)Padsevonil 200mg BID Taper and SFU Period (SS)Padsevonil 400mg BID Taper and SFU Period (SS)
SomnolenceNervous system disorders10/8319/8124/8325/8230/811/694/641/661/552/570/90/140/110/240/22
DizzinessNervous system disorders9/8318/8123/8319/8228/813/692/641/662/552/570/90/140/111/241/22
FatigueGeneral disorders10/8320/8112/8314/8220/813/695/642/661/550/570/90/140/111/240/22
HeadacheNervous system disorders10/8317/819/8315/829/810/693/642/660/551/571/90/140/112/241/22
Memory impairmentNervous system disorders1/833/811/838/8214/811/690/641/660/550/570/90/140/110/241/22
Urinary tract infectionInfections and infestations2/831/811/830/822/811/690/641/660/550/571/90/140/110/241/22
Ligament sprainInjury, poisoning and procedural complications0/832/810/830/820/810/692/640/660/550/571/90/140/110/240/22
Platelet count decreasedInvestigations0/830/811/830/820/810/690/640/660/550/571/90/140/110/240/22
Anticonvulsant drug level increasedInvestigations0/830/810/830/820/810/690/640/660/550/571/90/140/110/240/22
Back painMusculoskeletal and connective tissue disorders0/831/812/832/825/810/690/640/660/550/571/90/140/110/240/22

Baseline characteristics

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

Age, Categorical
Age, Categorical(Participants)PlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BIDTotal Title
<=18 years002114
Between 18 and 65 years8276807980397
>=65 years1512110
Age, Continuous
Age, Continuous(years)PlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BIDTotal Title
Mean40.0 ± 12.942.5 ± 11.636.9 ± 13.140.9 ± 12.038.8 ± 12.139.8 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BIDTotal Title
Female4846475143235
Male3535363139176
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboPadsevonil 50mg BIDPadsevonil 100mg BIDPadsevonil 200mg BIDPadsevonil 400mg BIDTotal Title
American Indian or Alaska Native111205
Asian7757733
Black or African American211228
Native Hawaiian or Other Pacific Islander111115
White6969736971351
Other/mixed322119
08

Study locations

148 sites
  • Ep0091 839
    Chandler, Arizona 85226, United States
  • Ep0091 810
    Little Rock, Arkansas 72205, United States
  • Ep0091 815
    La Jolla, California 92037, United States
  • Ep0091 801
    San Francisco, California 94115, United States
  • Ep0091 845
    Washington, District of Columbia 20037, United States
  • Ep0091 809
    Ocala, Florida 34471, United States
  • Ep0091 823
    Orlando, Florida 32806, United States
  • Ep0091 825
    Port Charlotte, Florida 33952, United States
  • Ep0091 820
    Tallahassee, Florida 32308, United States
  • Ep0091 873
    Atlanta, Georgia 30303, United States
  • Ep0091 803
    Honolulu, Hawaii 96817, United States
  • Ep0091 832
    Peoria, Illinois 61637, United States
  • Ep0091 822
    Baltimore, Maryland 21287, United States
  • Ep0091 818
    Bethesda, Maryland 20817, United States
  • Ep0091 817
    Saint Paul, Minnesota 55102, United States
  • Ep0091 806
    Hackensack, New Jersey 07601, United States
  • Ep0091 827
    New York, New York 10016-48, United States
  • Ep0091 800
    Philadelphia, Pennsylvania 19104, United States
  • Ep0091 802
    Philadelphia, Pennsylvania 19107, United States
  • Ep0091 838
    Cordova, Tennessee 38018, United States
  • Ep0091 835
    Nashville, Tennessee 37232, United States
  • Ep0091 805
    Austin, Texas 78701, United States
  • Ep0091 844
    Austin, Texas 78758, United States
  • Ep0091 836
    Dallas, Texas 75231, United States
  • Ep0091 830
    Dallas, Texas 75390-91, United States
  • Ep0091 824
    Round Rock, Texas 78681, United States
  • Ep0091 870
    San Antonio, Texas 78229, United States
  • Ep0091 855
    Box Hill, Australia
  • Ep0091 857
    Clayton, Australia
  • Ep0091 850
    Fitzroy, Australia
  • Ep0091 859
    Herston, Australia
  • Ep0091 852
    Melbourne, Australia
  • Ep0091 853
    Melbourne, Australia
  • Ep0091 856
    Randwick, Australia
  • Ep0091 854
    Westmead, Australia
  • Ep0091 102
    Brugge, Belgium
  • Ep0091 101
    Brussels, Belgium
  • Ep0091 105
    Gent, Belgium
  • Ep0091 100
    Leuven, Belgium
  • Ep0091 150
    Blagoevgrad, Bulgaria
  • Ep0091 151
    Pleven, Bulgaria
  • Ep0091 153
    Pleven, Bulgaria
  • Ep0091 152
    Sofia, Bulgaria
  • Ep0091 154
    Sofia, Bulgaria
  • Ep0091 155
    Sofia, Bulgaria
  • Ep0091 200
    Greenfield Park, Canada
  • Ep0091 205
    London, Canada
  • Ep0091 201
    Montréal, Canada
  • Ep0091 254
    Brno, Czechia
  • Ep0091 255
    Ostrava-Poruba, Czechia
  • Ep0091 252
    Praha 4, Czechia
  • Ep0091 250
    Praha 5, Czechia
  • Ep0091 253
    Praha 8, Czechia
  • Ep0091 251
    Praha, Czechia
  • Ep0091 307
    Clermont-Ferrand Cedex 1, France
  • Ep0091 309
    Dijon, France
  • Ep0091 300
    Lille, France
  • Ep0091 302
    Montpellier, France
  • Ep0091 305
    Paris, France
  • Ep0091 303
    Rennes, France
  • Ep0091 306
    Toulouse Cedex 9, France
  • Ep0091 361
    Bad Neustadt An Der Saale, Germany
  • Ep0091 365
    Berlin, Germany
  • Ep0091 362
    Bernau, Germany
  • Ep0091 363
    Bielefeld, Germany
  • Ep0091 358
    Bonn, Germany
  • Ep0091 350
    Frankfurt am main, Germany
  • Ep0091 360
    Freiburg, Germany
  • Ep0091 364
    Hamburg, Germany
  • Ep0091 368
    Jena, Germany
  • Ep0091 366
    Kork, Germany
  • Ep0091 357
    Leipzig, Germany
  • Ep0091 353
    Marburg, Germany
  • Ep0091 354
    München, Germany
  • Ep0091 351
    Münster, Germany
  • Ep0091 356
    Osnabrück, Germany
  • Ep0091 367
    Ravensburg, Germany
  • Ep0091 301
    Strausberg, Germany
  • Ep0091 352
    Tübingen, Germany
  • Ep0091 400
    Budapest, Hungary
  • Ep0091 403
    Budapest, Hungary
  • Ep0091 402
    Debrecen, Hungary
  • Ep0091 462
    Bologna, Italy
  • Ep0091 450
    Cagliari, Italy
  • Ep0091 461
    Foggia, Italy
  • Ep0091 452
    Milano, Italy
  • Ep0091 459
    Pavia, Italy
  • Ep0091 453
    Perugia, Italy
  • Ep0091 458
    Pozzilli, Italy
  • Ep0091 454
    Reggio Calabria, Italy
  • Ep0091 455
    Roma, Italy
  • Ep0091 457
    Roma, Italy
  • Ep0091 460
    Roma, Italy
  • Ep0091 501
    Asaka, Japan
  • Ep0091 511
    Fukuoka, Japan
  • Ep0091 505
    Hiroshima, Japan
  • Ep0091 513
    Hōfu, Japan
  • Ep0091 507
    Itami, Japan
  • Ep0091 503
    Kodaira, Japan
  • Ep0091 514
    Kyoto, Japan

Showing the first 100 of 148 sites across 19 countries. Choose a country and city above to see the rest.

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 ↗
  • Kramer H, Bicer C, Otoul C, Rospo C, Macpherson M, Watling M, Bani M, Sciberras D, Chanteux H. Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development. AAPS J. 2023 Nov 16;26(1):1. doi: 10.1208/s12248-023-00866-7. PubMed 37973662 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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, Statistical analysis plan, Clinical study report

Time frame: 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.

Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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 pre-specified time, typically 12 months, on a password protected portal.

Data sharing details ↗ · www.vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jan 2020, 23 months.

Results were first posted in Apr 2021, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Dec 14, 2017
StartActual
Feb 12, 2018
Primary completionActual
Jan 30, 2020
CompletionActual
Jan 30, 2020
Results first posted
Apr 9, 2021
Last update
Dec 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03373383
Lead sponsor
UCB Biopharma S.P.R.L.
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Feb 12, 2018
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020
Results posted
Apr 9, 2021
Last update
Dec 19, 2023

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 completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Padsevonil

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