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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)

Primary Purpose

Drug-Resistant Epilepsy, Focal-Onset Seizures

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Padsevonil
Placebo
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-Resistant Epilepsy focused on measuring Epilepsy, Padsevonil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Ep0092 839
  • Ep0092 881
  • Ep0092 633
  • Ep0092 629
  • Ep0092 845
  • Ep0092 892
  • Ep0092 640
  • Ep0092 641
  • Ep0092 823
  • Ep0092 803
  • Ep0092 637
  • Ep0092 880
  • Ep0092 638
  • Ep0092 630
  • Ep0092 707
  • Ep0092 822
  • Ep0092 818
  • Ep0092 889
  • Ep0092 645
  • Ep0092 644
  • Ep0092 895
  • Ep0092 878
  • Ep0092 876
  • Ep0092 893
  • Ep0092 890
  • Ep0092 884
  • Ep0092 642
  • Ep0092 647
  • Ep0092 882
  • Ep0092 802
  • Ep0092 829
  • Ep0092 639
  • Ep0092 855
  • Ep0092 861
  • Ep0092 850
  • Ep0092 853
  • Ep0092 852
  • Ep0092 109
  • Ep0092 107
  • Ep0092 080
  • Ep0092 077
  • Ep0092 075
  • Ep0092 082
  • Ep0092 150
  • Ep0092 151
  • Ep0092 156
  • Ep0092 154
  • Ep0092 125
  • Ep0092 126
  • Ep0092 127
  • Ep0092 128
  • Ep0092 254
  • Ep0092 258
  • Ep0092 250
  • Ep0092 251
  • Ep0092 016
  • Ep0092 015
  • Ep0092 276
  • Ep0092 277
  • Ep0092 275
  • Ep0092 027
  • Ep0092 312
  • Ep0092 310
  • Ep0092 301
  • Ep0092 365
  • Ep0092 362
  • Ep0092 363
  • Ep0092 350
  • Ep0092 368
  • Ep0092 357
  • Ep0092 376
  • Ep0092 425
  • Ep0092 426
  • Ep0092 427
  • Ep0092 428
  • Ep0092 403
  • Ep0092 405
  • Ep0092 404
  • Ep0092 035
  • Ep0092 036
  • Ep0092 452
  • Ep0092 526
  • Ep0092 501
  • Ep0092 521
  • Ep0092 525
  • Ep0092 504
  • Ep0092 505
  • Ep0092 513
  • Ep0092 507
  • Ep0092 531
  • Ep0092 539
  • Ep0092 533
  • Ep0092 514
  • Ep0092 512
  • Ep0092 515
  • Ep0092 508
  • Ep0092 527
  • Ep0092 509
  • Ep0092 529
  • Ep0092 522
  • Ep0092 530
  • Ep0092 775
  • Ep0092 605
  • Ep0092 616
  • Ep0092 603
  • Ep0092 614
  • Ep0092 610
  • Ep0092 620
  • Ep0092 606
  • Ep0092 611
  • Ep0092 615
  • Ep0092 619
  • Ep0092 618
  • Ep0092 612
  • Ep0092 952
  • Ep0092 950
  • Ep0092 925
  • Ep0092 926
  • Ep0092 927
  • Ep0092 327
  • Ep0092 325
  • Ep0092 004
  • Ep0092 662
  • Ep0092 651
  • Ep0092 652
  • Ep0092 658
  • Ep0092 674
  • Ep0092 657
  • Ep0092 676
  • Ep0092 576
  • Ep0092 575
  • Ep0092 053
  • Ep0092 913
  • Ep0092 915
  • Ep0092 900
  • Ep0092 906
  • Ep0092 909
  • Ep0092 908
  • Ep0092 766
  • Ep0092 750
  • Ep0092 764

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Padsevonil dosing regimen 1

Padsevonil dosing regimen 2

Padsevonil dosing regimen 3

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 9, 2018
Last Updated
December 19, 2022
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03739840
Brief Title
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Acronym
DUET
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Resistant Epilepsy, Focal-Onset Seizures
Keywords
Epilepsy, Padsevonil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Padsevonil dosing regimen 1
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.
Arm Title
Padsevonil dosing regimen 2
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.
Arm Title
Padsevonil dosing regimen 3
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the placebo group will receive a combination of several placebo tablets to maintain the blinding.
Intervention Type
Drug
Intervention Name(s)
Padsevonil
Intervention Description
Padsevonil in different dosages.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be provided matching padsevonil.
Primary Outcome Measure Information:
Title
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
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)
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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)
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
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)
Title
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
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)
Secondary Outcome Measure Information:
Title
75% Responder Rate From Baseline Over the 12-week Maintenance Period
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)
Title
50% Responder Rate From Baseline Over the 12-week Maintenance Period
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)
Title
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ep0092 839
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Facility Name
Ep0092 881
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Ep0092 633
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Ep0092 629
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ep0092 845
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Ep0092 892
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Ep0092 640
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Ep0092 641
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Ep0092 823
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ep0092 803
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Ep0092 637
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Ep0092 880
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Ep0092 638
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Ep0092 630
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Ep0092 707
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ep0092 822
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ep0092 818
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Ep0092 889
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Ep0092 645
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Ep0092 644
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Ep0092 895
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Ep0092 878
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Ep0092 876
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Ep0092 893
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ep0092 890
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ep0092 884
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ep0092 642
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ep0092 647
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Ep0092 882
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Ep0092 802
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Ep0092 829
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Ep0092 639
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Ep0092 855
City
Box Hill
Country
Australia
Facility Name
Ep0092 861
City
Camperdown
Country
Australia
Facility Name
Ep0092 850
City
Fitzroy
Country
Australia
Facility Name
Ep0092 853
City
Heidelberg
Country
Australia
Facility Name
Ep0092 852
City
Melbourne
Country
Australia
Facility Name
Ep0092 109
City
Brussels
Country
Belgium
Facility Name
Ep0092 107
City
Ottignies
Country
Belgium
Facility Name
Ep0092 080
City
Bihać
Country
Bosnia and Herzegovina
Facility Name
Ep0092 077
City
Mostar
Country
Bosnia and Herzegovina
Facility Name
Ep0092 075
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Ep0092 082
City
Tuzla
Country
Bosnia and Herzegovina
Facility Name
Ep0092 150
City
Blagoevgrad
Country
Bulgaria
Facility Name
Ep0092 151
City
Pleven
Country
Bulgaria
Facility Name
Ep0092 156
City
Pleven
Country
Bulgaria
Facility Name
Ep0092 154
City
Sofia
Country
Bulgaria
Facility Name
Ep0092 125
City
Zagreb
Country
Croatia
Facility Name
Ep0092 126
City
Zagreb
Country
Croatia
Facility Name
Ep0092 127
City
Zagreb
Country
Croatia
Facility Name
Ep0092 128
City
Zagreb
Country
Croatia
Facility Name
Ep0092 254
City
Brno
Country
Czechia
Facility Name
Ep0092 258
City
Ostrava
Country
Czechia
Facility Name
Ep0092 250
City
Praha 5
Country
Czechia
Facility Name
Ep0092 251
City
Praha 6
Country
Czechia
Facility Name
Ep0092 016
City
Aarhus
Country
Denmark
Facility Name
Ep0092 015
City
Odense
Country
Denmark
Facility Name
Ep0092 276
City
Tallinn
Country
Estonia
Facility Name
Ep0092 277
City
Tallinn
Country
Estonia
Facility Name
Ep0092 275
City
Tartu
Country
Estonia
Facility Name
Ep0092 027
City
Tampere
Country
Finland
Facility Name
Ep0092 312
City
Lyon
Country
France
Facility Name
Ep0092 310
City
Paris
Country
France
Facility Name
Ep0092 301
City
Strasbourg
Country
France
Facility Name
Ep0092 365
City
Berlin
Country
Germany
Facility Name
Ep0092 362
City
Bernau
Country
Germany
Facility Name
Ep0092 363
City
Bielefeld
Country
Germany
Facility Name
Ep0092 350
City
Frankfurt
Country
Germany
Facility Name
Ep0092 368
City
Jena
Country
Germany
Facility Name
Ep0092 357
City
Leipzig
Country
Germany
Facility Name
Ep0092 376
City
Regensburg
Country
Germany
Facility Name
Ep0092 425
City
Ioánnina
Country
Greece
Facility Name
Ep0092 426
City
Thessaloníki
Country
Greece
Facility Name
Ep0092 427
City
Thessaloníki
Country
Greece
Facility Name
Ep0092 428
City
Thessaloníki
Country
Greece
Facility Name
Ep0092 403
City
Budapest
Country
Hungary
Facility Name
Ep0092 405
City
Debrecen
Country
Hungary
Facility Name
Ep0092 404
City
Pécs
Country
Hungary
Facility Name
Ep0092 035
City
Cork
Country
Ireland
Facility Name
Ep0092 036
City
Dublin
Country
Ireland
Facility Name
Ep0092 452
City
Milano
Country
Italy
Facility Name
Ep0092 526
City
Asahikawa
Country
Japan
Facility Name
Ep0092 501
City
Asaka
Country
Japan
Facility Name
Ep0092 521
City
Bunkyō-Ku
Country
Japan
Facility Name
Ep0092 525
City
Bunkyō-Ku
Country
Japan
Facility Name
Ep0092 504
City
Hamamatsu
Country
Japan
Facility Name
Ep0092 505
City
Hiroshima
Country
Japan
Facility Name
Ep0092 513
City
Hōfu
Country
Japan
Facility Name
Ep0092 507
City
Itami
Country
Japan
Facility Name
Ep0092 531
City
Izumi
Country
Japan
Facility Name
Ep0092 539
City
Kumamoto
Country
Japan
Facility Name
Ep0092 533
City
Kure
Country
Japan
Facility Name
Ep0092 514
City
Kyoto
Country
Japan
Facility Name
Ep0092 512
City
Nagakute
Country
Japan
Facility Name
Ep0092 515
City
Saitama
Country
Japan
Facility Name
Ep0092 508
City
Sapporo
Country
Japan
Facility Name
Ep0092 527
City
Shinagawa-Ku
Country
Japan
Facility Name
Ep0092 509
City
Shizuoka
Country
Japan
Facility Name
Ep0092 529
City
Yonago
Country
Japan
Facility Name
Ep0092 522
City
Ōmura
Country
Japan
Facility Name
Ep0092 530
City
Ōsaka-sayama
Country
Japan
Facility Name
Ep0092 775
City
Sandvika
Country
Norway
Facility Name
Ep0092 605
City
Katowice
Country
Poland
Facility Name
Ep0092 616
City
Katowice
Country
Poland
Facility Name
Ep0092 603
City
Kraków
Country
Poland
Facility Name
Ep0092 614
City
Kraków
Country
Poland
Facility Name
Ep0092 610
City
Lublin
Country
Poland
Facility Name
Ep0092 620
City
Lublin
Country
Poland
Facility Name
Ep0092 606
City
Nowa Sól
Country
Poland
Facility Name
Ep0092 611
City
Warszawa
Country
Poland
Facility Name
Ep0092 615
City
Wrocław
Country
Poland
Facility Name
Ep0092 619
City
Zamość
Country
Poland
Facility Name
Ep0092 618
City
Zgierz
Country
Poland
Facility Name
Ep0092 612
City
Łódź
Country
Poland
Facility Name
Ep0092 952
City
Aveiro
Country
Portugal
Facility Name
Ep0092 950
City
Matosinhos
Country
Portugal
Facility Name
Ep0092 925
City
Bucuresti
Country
Romania
Facility Name
Ep0092 926
City
Bucuresti
Country
Romania
Facility Name
Ep0092 927
City
Târgu-Mureş
Country
Romania
Facility Name
Ep0092 327
City
Belgrade
Country
Serbia
Facility Name
Ep0092 325
City
Novi Sad
Country
Serbia
Facility Name
Ep0092 004
City
Bardejov
Country
Slovakia
Facility Name
Ep0092 662
City
Alicante
Country
Spain
Facility Name
Ep0092 651
City
Barcelona
Country
Spain
Facility Name
Ep0092 652
City
Barcelona
Country
Spain
Facility Name
Ep0092 658
City
Barcelona
Country
Spain
Facility Name
Ep0092 674
City
Madrid
Country
Spain
Facility Name
Ep0092 657
City
Valencia
Country
Spain
Facility Name
Ep0092 676
City
Zaragoza
Country
Spain
Facility Name
Ep0092 576
City
Göteborg
Country
Sweden
Facility Name
Ep0092 575
City
Linköping
Country
Sweden
Facility Name
Ep0092 053
City
Zürich
Country
Switzerland
Facility Name
Ep0092 913
City
Ankara
Country
Turkey
Facility Name
Ep0092 915
City
Antalya
Country
Turkey
Facility Name
Ep0092 900
City
Istanbul
Country
Turkey
Facility Name
Ep0092 906
City
Istanbul
Country
Turkey
Facility Name
Ep0092 909
City
Istanbul
Country
Turkey
Facility Name
Ep0092 908
City
Trabzon
Country
Turkey
Facility Name
Ep0092 766
City
Brighton
Country
United Kingdom
Facility Name
Ep0092 750
City
Manchester
Country
United Kingdom
Facility Name
Ep0092 764
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://www.Vivli.org
Citations:
PubMed Identifier
36176044
Citation
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.
Results Reference
result

Learn more about this trial

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

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