Back to resultsStudy to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy (ARISE)
Primary Purpose
Drug-resistant Epilepsy, Focal-Onset Seizures
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Padsevonil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Drug-resistant Epilepsy focused on measuring Epilepsy, Padsevonil
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
Sites / Locations
- Ep0091 839
- Ep0091 810
- Ep0091 815
- Ep0091 801
- Ep0091 845
- Ep0091 809
- Ep0091 823
- Ep0091 825
- Ep0091 820
- Ep0091 873
- Ep0091 803
- Ep0091 832
- Ep0091 822
- Ep0091 818
- Ep0091 817
- Ep0091 806
- Ep0091 827
- Ep0091 800
- Ep0091 802
- Ep0091 838
- Ep0091 835
- Ep0091 805
- Ep0091 844
- Ep0091 836
- Ep0091 830
- Ep0091 824
- Ep0091 870
- Ep0091 855
- Ep0091 857
- Ep0091 850
- Ep0091 859
- Ep0091 852
- Ep0091 853
- Ep0091 856
- Ep0091 854
- Ep0091 102
- Ep0091 101
- Ep0091 105
- Ep0091 100
- Ep0091 150
- Ep0091 151
- Ep0091 153
- Ep0091 152
- Ep0091 154
- Ep0091 155
- Ep0091 200
- Ep0091 205
- Ep0091 201
- Ep0091 254
- Ep0091 255
- Ep0091 252
- Ep0091 250
- Ep0091 253
- Ep0091 251
- Ep0091 307
- Ep0091 309
- Ep0091 300
- Ep0091 302
- Ep0091 305
- Ep0091 303
- Ep0091 306
- Ep0091 361
- Ep0091 365
- Ep0091 362
- Ep0091 363
- Ep0091 358
- Ep0091 350
- Ep0091 360
- Ep0091 364
- Ep0091 368
- Ep0091 366
- Ep0091 357
- Ep0091 353
- Ep0091 354
- Ep0091 351
- Ep0091 356
- Ep0091 367
- Ep0091 301
- Ep0091 352
- Ep0091 400
- Ep0091 403
- Ep0091 402
- Ep0091 462
- Ep0091 450
- Ep0091 461
- Ep0091 452
- Ep0091 459
- Ep0091 453
- Ep0091 458
- Ep0091 454
- Ep0091 455
- Ep0091 457
- Ep0091 460
- Ep0091 501
- Ep0091 511
- Ep0091 505
- Ep0091 513
- Ep0091 507
- Ep0091 503
- Ep0091 514
- Ep0091 512
- Ep0091 510
- Ep0091 515
- Ep0091 509
- Ep0091 703
- Ep0091 701
- Ep0091 702
- Ep0091 553
- Ep0091 552
- Ep0091 601
- Ep0091 607
- Ep0091 605
- Ep0091 608
- Ep0091 603
- Ep0091 604
- Ep0091 606
- Ep0091 600
- Ep0091 609
- Ep0091 602
- Ep0091 952
- Ep0091 004
- Ep0091 001
- Ep0091 662
- Ep0091 651
- Ep0091 652
- Ep0091 658
- Ep0091 664
- Ep0091 668
- Ep0091 666
- Ep0091 650
- Ep0091 656
- Ep0091 660
- Ep0091 661
- Ep0091 659
- Ep0091 663
- Ep0091 665
- Ep0091 657
- Ep0091 667
- Ep0091 653
- Ep0091 904
- Ep0091 900
- Ep0091 901
- Ep0091 752
- Ep0091 751
- Ep0091 756
- Ep0091 757
- Ep0091 750
- Ep0091 753
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Padsevonil dosing regimen 1
Padsevonil dosing regimen 2
Padsevonil dosing regimen 3
Padsevonil dosing regimen 4
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 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, 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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03373383
First Posted
December 7, 2017
Last Updated
December 19, 2022
Sponsor
UCB Biopharma S.P.R.L.
1. Study Identification
Unique Protocol Identification Number
NCT03373383
Brief Title
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
Acronym
ARISE
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose Finding 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
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
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 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.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (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
Padsevonil dosing regimen 4
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
Other
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, 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
Title
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
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.
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.
Time Frame
From Baseline until Safety Follow-Up (up to Week 23)
Title
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study
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 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 Outcome Measure Information:
Title
75 % Responder Rate Over the 12 Week Maintenance Period
Description
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
Title
50 % Responder Rate 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
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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) was assessed.
Time Frame
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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
Ep0091 839
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Facility Name
Ep0091 810
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Ep0091 815
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Ep0091 801
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Ep0091 845
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Ep0091 809
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ep0091 823
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ep0091 825
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Ep0091 820
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Ep0091 873
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Ep0091 803
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Ep0091 832
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Ep0091 822
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ep0091 818
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Ep0091 817
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ep0091 806
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Ep0091 827
City
New York
State/Province
New York
ZIP/Postal Code
10016-48
Country
United States
Facility Name
Ep0091 800
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Ep0091 802
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Ep0091 838
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Ep0091 835
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Ep0091 805
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Ep0091 844
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Ep0091 836
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ep0091 830
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-91
Country
United States
Facility Name
Ep0091 824
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Ep0091 870
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ep0091 855
City
Box Hill
Country
Australia
Facility Name
Ep0091 857
City
Clayton
Country
Australia
Facility Name
Ep0091 850
City
Fitzroy
Country
Australia
Facility Name
Ep0091 859
City
Herston
Country
Australia
Facility Name
Ep0091 852
City
Melbourne
Country
Australia
Facility Name
Ep0091 853
City
Melbourne
Country
Australia
Facility Name
Ep0091 856
City
Randwick
Country
Australia
Facility Name
Ep0091 854
City
Westmead
Country
Australia
Facility Name
Ep0091 102
City
Brugge
Country
Belgium
Facility Name
Ep0091 101
City
Brussels
Country
Belgium
Facility Name
Ep0091 105
City
Gent
Country
Belgium
Facility Name
Ep0091 100
City
Leuven
Country
Belgium
Facility Name
Ep0091 150
City
Blagoevgrad
Country
Bulgaria
Facility Name
Ep0091 151
City
Pleven
Country
Bulgaria
Facility Name
Ep0091 153
City
Pleven
Country
Bulgaria
Facility Name
Ep0091 152
City
Sofia
Country
Bulgaria
Facility Name
Ep0091 154
City
Sofia
Country
Bulgaria
Facility Name
Ep0091 155
City
Sofia
Country
Bulgaria
Facility Name
Ep0091 200
City
Greenfield Park
Country
Canada
Facility Name
Ep0091 205
City
London
Country
Canada
Facility Name
Ep0091 201
City
Montréal
Country
Canada
Facility Name
Ep0091 254
City
Brno
Country
Czechia
Facility Name
Ep0091 255
City
Ostrava-Poruba
Country
Czechia
Facility Name
Ep0091 252
City
Praha 4
Country
Czechia
Facility Name
Ep0091 250
City
Praha 5
Country
Czechia
Facility Name
Ep0091 253
City
Praha 8
Country
Czechia
Facility Name
Ep0091 251
City
Praha
Country
Czechia
Facility Name
Ep0091 307
City
Clermont-Ferrand Cedex 1
Country
France
Facility Name
Ep0091 309
City
Dijon
Country
France
Facility Name
Ep0091 300
City
Lille
Country
France
Facility Name
Ep0091 302
City
Montpellier
Country
France
Facility Name
Ep0091 305
City
Paris
Country
France
Facility Name
Ep0091 303
City
Rennes
Country
France
Facility Name
Ep0091 306
City
Toulouse Cedex 9
Country
France
Facility Name
Ep0091 361
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Ep0091 365
City
Berlin
Country
Germany
Facility Name
Ep0091 362
City
Bernau
Country
Germany
Facility Name
Ep0091 363
City
Bielefeld
Country
Germany
Facility Name
Ep0091 358
City
Bonn
Country
Germany
Facility Name
Ep0091 350
City
Frankfurt am main
Country
Germany
Facility Name
Ep0091 360
City
Freiburg
Country
Germany
Facility Name
Ep0091 364
City
Hamburg
Country
Germany
Facility Name
Ep0091 368
City
Jena
Country
Germany
Facility Name
Ep0091 366
City
Kork
Country
Germany
Facility Name
Ep0091 357
City
Leipzig
Country
Germany
Facility Name
Ep0091 353
City
Marburg
Country
Germany
Facility Name
Ep0091 354
City
München
Country
Germany
Facility Name
Ep0091 351
City
Münster
Country
Germany
Facility Name
Ep0091 356
City
Osnabrück
Country
Germany
Facility Name
Ep0091 367
City
Ravensburg
Country
Germany
Facility Name
Ep0091 301
City
Strausberg
Country
Germany
Facility Name
Ep0091 352
City
Tübingen
Country
Germany
Facility Name
Ep0091 400
City
Budapest
Country
Hungary
Facility Name
Ep0091 403
City
Budapest
Country
Hungary
Facility Name
Ep0091 402
City
Debrecen
Country
Hungary
Facility Name
Ep0091 462
City
Bologna
Country
Italy
Facility Name
Ep0091 450
City
Cagliari
Country
Italy
Facility Name
Ep0091 461
City
Foggia
Country
Italy
Facility Name
Ep0091 452
City
Milano
Country
Italy
Facility Name
Ep0091 459
City
Pavia
Country
Italy
Facility Name
Ep0091 453
City
Perugia
Country
Italy
Facility Name
Ep0091 458
City
Pozzilli
Country
Italy
Facility Name
Ep0091 454
City
Reggio Calabria
Country
Italy
Facility Name
Ep0091 455
City
Roma
Country
Italy
Facility Name
Ep0091 457
City
Roma
Country
Italy
Facility Name
Ep0091 460
City
Roma
Country
Italy
Facility Name
Ep0091 501
City
Asaka
Country
Japan
Facility Name
Ep0091 511
City
Fukuoka
Country
Japan
Facility Name
Ep0091 505
City
Hiroshima
Country
Japan
Facility Name
Ep0091 513
City
Hōfu
Country
Japan
Facility Name
Ep0091 507
City
Itami
Country
Japan
Facility Name
Ep0091 503
City
Kodaira
Country
Japan
Facility Name
Ep0091 514
City
Kyoto
Country
Japan
Facility Name
Ep0091 512
City
Nagakute
Country
Japan
Facility Name
Ep0091 510
City
Niigata
Country
Japan
Facility Name
Ep0091 515
City
Saitama
Country
Japan
Facility Name
Ep0091 509
City
Shizuoka
Country
Japan
Facility Name
Ep0091 703
City
Kaunas
Country
Lithuania
Facility Name
Ep0091 701
City
Vilnius
Country
Lithuania
Facility Name
Ep0091 702
City
Vilnius
Country
Lithuania
Facility Name
Ep0091 553
City
Culiacán
Country
Mexico
Facility Name
Ep0091 552
City
Mexico Distrito Federal
Country
Mexico
Facility Name
Ep0091 601
City
Gdańsk
Country
Poland
Facility Name
Ep0091 607
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Ep0091 605
City
Katowice
Country
Poland
Facility Name
Ep0091 608
City
Katowice
Country
Poland
Facility Name
Ep0091 603
City
Kraków
Country
Poland
Facility Name
Ep0091 604
City
Lublin
Country
Poland
Facility Name
Ep0091 606
City
Nowa Sól
Country
Poland
Facility Name
Ep0091 600
City
Poznań
Country
Poland
Facility Name
Ep0091 609
City
Poznań
Country
Poland
Facility Name
Ep0091 602
City
Świdnik
Country
Poland
Facility Name
Ep0091 952
City
Santa Maria Da Feira
Country
Portugal
Facility Name
Ep0091 004
City
Bardejov
Country
Slovakia
Facility Name
Ep0091 001
City
Hlohovec
Country
Slovakia
Facility Name
Ep0091 662
City
Alicante
Country
Spain
Facility Name
Ep0091 651
City
Barcelona
Country
Spain
Facility Name
Ep0091 652
City
Barcelona
Country
Spain
Facility Name
Ep0091 658
City
Barcelona
Country
Spain
Facility Name
Ep0091 664
City
Barcelona
Country
Spain
Facility Name
Ep0091 668
City
Bilbao
Country
Spain
Facility Name
Ep0091 666
City
Córdoba
Country
Spain
Facility Name
Ep0091 650
City
Madrid
Country
Spain
Facility Name
Ep0091 656
City
Madrid
Country
Spain
Facility Name
Ep0091 660
City
Madrid
Country
Spain
Facility Name
Ep0091 661
City
Madrid
Country
Spain
Facility Name
Ep0091 659
City
Málaga
Country
Spain
Facility Name
Ep0091 663
City
Sevilla
Country
Spain
Facility Name
Ep0091 665
City
Terrassa
Country
Spain
Facility Name
Ep0091 657
City
Valencia
Country
Spain
Facility Name
Ep0091 667
City
Valencia
Country
Spain
Facility Name
Ep0091 653
City
Valladolid
Country
Spain
Facility Name
Ep0091 904
City
Eskişehir
Country
Turkey
Facility Name
Ep0091 900
City
Istanbul
Country
Turkey
Facility Name
Ep0091 901
City
Istanbul
Country
Turkey
Facility Name
Ep0091 752
City
Birmingham
Country
United Kingdom
Facility Name
Ep0091 751
City
Cardiff
Country
United Kingdom
Facility Name
Ep0091 756
City
Inverness
Country
United Kingdom
Facility Name
Ep0091 757
City
London
Country
United Kingdom
Facility Name
Ep0091 750
City
Manchester
Country
United Kingdom
Facility Name
Ep0091 753
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
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
We'll reach out to this number within 24 hrs