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

Primary Purpose

Drug-Resistant Epilepsy, Focal-Onset Seizures

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Padsevonil
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 Drug-Resistant Epilepsy, Padsevonil

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is an adult (18 years of age or more )
  • Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study
  • Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.

Exclusion Criteria:

  • Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject
  • Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit
  • Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (*according to the ASE Guidelines, 2017; Zoghbi et al 2017)
  • Female subject who plans to be pregnant or is breastfeeding

Sites / Locations

  • Ep0093 839
  • Ep0093 815
  • Ep0093 801
  • Ep0093 803
  • Ep0093 638
  • Ep0093 707
  • Ep0093 822
  • Ep0093 818
  • Ep0093 889
  • Ep0093 645
  • Ep0093 817
  • Ep0093 806
  • Ep0093 895
  • Ep0093 893
  • Ep0093 890
  • Ep0093 884
  • Ep0093 642
  • Ep0093 802
  • Ep0093 838
  • Ep0093 835
  • Ep0093 805
  • Ep0093 844
  • Ep0093 824
  • Ep0093 870
  • Ep0093 639
  • Ep0093 855
  • Ep0093 857
  • Ep0093 850
  • Ep0093 853
  • Ep0093 859
  • Ep0093 852
  • Ep0093 856
  • Ep0093 854
  • Ep0093 102
  • Ep0093 101
  • Ep0093 105
  • Ep0093 100
  • Ep0093 107
  • Ep0093 075
  • Ep0093 082
  • Ep0093 150
  • Ep0093 151
  • Ep0093 153
  • Ep0093 156
  • Ep0093 152
  • Ep0093 154
  • Ep0093 155
  • Ep0093 200
  • Ep0093 205
  • Ep0093 201
  • Ep0093 125
  • Ep0093 254
  • Ep0093 255
  • Ep0093 251
  • Ep0093 250
  • Ep0093 253
  • Ep0093 016
  • Ep0093 015
  • Ep0093 277
  • Ep0093 276
  • Ep0093 275
  • Ep0093 027
  • Ep0093 307
  • Ep0093 309
  • Ep0093 300
  • Ep0093 302
  • Ep0093 303
  • Ep0093 301
  • Ep0093 365
  • Ep0093 362
  • Ep0093 363
  • Ep0093 358
  • Ep0093 350
  • Ep0093 360
  • Ep0093 368
  • Ep0093 366
  • Ep0093 357
  • Ep0093 353
  • Ep0093 354
  • Ep0093 351
  • Ep0093 356
  • Ep0093 352
  • Ep0093 426
  • Ep0093 427
  • Ep0093 400
  • Ep0093 403
  • Ep0093 402
  • Ep0093 035
  • Ep0093 462
  • Ep0093 450
  • Ep0093 451
  • Ep0093 461
  • Ep0093 452
  • Ep0093 459
  • Ep0093 458
  • Ep0093 455
  • Ep0093 457
  • Ep0093 460
  • Ep0093 526
  • Ep0093 501
  • Ep0093 521
  • Ep0093 511
  • Ep0093 504
  • Ep0093 505
  • Ep0093 513
  • Ep0093 507
  • Ep0093 514
  • Ep0093 512
  • Ep0093 510
  • Ep0093 515
  • Ep0093 509
  • Ep0093 529
  • Ep0093 703
  • Ep0093 702
  • Ep0093 553
  • Ep0093 552
  • Ep0093 601
  • Ep0093 607
  • Ep0093 605
  • Ep0093 616
  • Ep0093 603
  • Ep0093 614
  • Ep0093 604
  • Ep0093 610
  • Ep0093 606
  • Ep0093 600
  • Ep0093 609
  • Ep0093 602
  • Ep0093 926
  • Ep0093 327
  • Ep0093 004
  • Ep0093 662
  • Ep0093 668
  • Ep0093 651
  • Ep0093 652
  • Ep0093 664
  • Ep0093 666
  • Ep0093 658
  • Ep0093 656
  • Ep0093 660
  • Ep0093 667
  • Ep0093 674
  • Ep0093 659
  • Ep0093 665
  • Ep0093 657
  • Ep0093 653
  • Ep0093 900
  • Ep0093 901
  • Ep0093 904
  • Ep0093 906
  • Ep0093 909
  • Ep0093 752
  • Ep0093 766
  • Ep0093 751
  • Ep0093 753
  • Ep0093 764

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Padsevonil

Arm Description

Padsevonil will be administered in an open-label manner. The individual starting dose of each subject will be the one at the end of the parent study. Once subjects enter EP0093 further individual dose adjustments are allowed after 1 week to the extent possible with the combination of tablet strengths available.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study
An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens 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 participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period
Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2017
Last Updated
November 30, 2021
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03370120
Brief Title
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Official Title
An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy 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
November 2021
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
August 27, 2018 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
December 11, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for 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
Drug-Resistant Epilepsy, Padsevonil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Padsevonil
Arm Type
Experimental
Arm Description
Padsevonil will be administered in an open-label manner. The individual starting dose of each subject will be the one at the end of the parent study. Once subjects enter EP0093 further individual dose adjustments are allowed after 1 week to the extent possible with the combination of tablet strengths available.
Intervention Type
Drug
Intervention Name(s)
Padsevonil
Intervention Description
Pharmaceutical Form: film-coated tablet Route of Administration: Oral use
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study
Description
An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Time Frame
From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
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 participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Time Frame
From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Title
Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period
Description
Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.
Time Frame
From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is an adult (18 years of age or more ) Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL. Exclusion Criteria: Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS) Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (*according to the ASE Guidelines, 2017; Zoghbi et al 2017) Female subject who plans to be pregnant or is breastfeeding
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
Ep0093 839
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Facility Name
Ep0093 815
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Ep0093 801
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Ep0093 803
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Ep0093 638
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Ep0093 707
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ep0093 822
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ep0093 818
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Ep0093 889
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Ep0093 645
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Ep0093 817
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ep0093 806
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Ep0093 895
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-24 01
Country
United States
Facility Name
Ep0093 893
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ep0093 890
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Ep0093 884
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ep0093 642
City
Columbia
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ep0093 802
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Ep0093 838
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Ep0093 835
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Ep0093 805
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Ep0093 844
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Ep0093 824
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Ep0093 870
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ep0093 639
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Ep0093 855
City
Box Hill
Country
Australia
Facility Name
Ep0093 857
City
Clayton
Country
Australia
Facility Name
Ep0093 850
City
Fitzroy
Country
Australia
Facility Name
Ep0093 853
City
Heidelberg
Country
Australia
Facility Name
Ep0093 859
City
Herston
Country
Australia
Facility Name
Ep0093 852
City
Melbourne
Country
Australia
Facility Name
Ep0093 856
City
Randwick
Country
Australia
Facility Name
Ep0093 854
City
Westmead
Country
Australia
Facility Name
Ep0093 102
City
Brugge
Country
Belgium
Facility Name
Ep0093 101
City
Brussels
Country
Belgium
Facility Name
Ep0093 105
City
Gent
Country
Belgium
Facility Name
Ep0093 100
City
Leuven
Country
Belgium
Facility Name
Ep0093 107
City
Ottignies
Country
Belgium
Facility Name
Ep0093 075
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Ep0093 082
City
Tuzla
Country
Bosnia and Herzegovina
Facility Name
Ep0093 150
City
Blagoevgrad
Country
Bulgaria
Facility Name
Ep0093 151
City
Pleven
Country
Bulgaria
Facility Name
Ep0093 153
City
Pleven
Country
Bulgaria
Facility Name
Ep0093 156
City
Pleven
Country
Bulgaria
Facility Name
Ep0093 152
City
Sofia
Country
Bulgaria
Facility Name
Ep0093 154
City
Sofia
Country
Bulgaria
Facility Name
Ep0093 155
City
Sofia
Country
Bulgaria
Facility Name
Ep0093 200
City
Greenfield Park
Country
Canada
Facility Name
Ep0093 205
City
London
Country
Canada
Facility Name
Ep0093 201
City
Montréal
Country
Canada
Facility Name
Ep0093 125
City
Zagreb
Country
Croatia
Facility Name
Ep0093 254
City
Brno
Country
Czechia
Facility Name
Ep0093 255
City
Ostrava
Country
Czechia
Facility Name
Ep0093 251
City
Praha 6
Country
Czechia
Facility Name
Ep0093 250
City
Praha
Country
Czechia
Facility Name
Ep0093 253
City
Praha
Country
Czechia
Facility Name
Ep0093 016
City
Aarhus
Country
Denmark
Facility Name
Ep0093 015
City
Odense
Country
Denmark
Facility Name
Ep0093 277
City
Tallinn
Country
Estonia
Facility Name
Ep0093 276
City
Tallin
Country
Estonia
Facility Name
Ep0093 275
City
Tartu
Country
Estonia
Facility Name
Ep0093 027
City
Tampere
Country
Finland
Facility Name
Ep0093 307
City
Clermont-Ferrand
Country
France
Facility Name
Ep0093 309
City
Dijon
Country
France
Facility Name
Ep0093 300
City
Lille
Country
France
Facility Name
Ep0093 302
City
Montpellier
Country
France
Facility Name
Ep0093 303
City
Rennes
Country
France
Facility Name
Ep0093 301
City
Strasbourg
Country
France
Facility Name
Ep0093 365
City
Berlin
Country
Germany
Facility Name
Ep0093 362
City
Bernau
Country
Germany
Facility Name
Ep0093 363
City
Bielefeld
Country
Germany
Facility Name
Ep0093 358
City
Bonn
Country
Germany
Facility Name
Ep0093 350
City
Frankfurt
Country
Germany
Facility Name
Ep0093 360
City
Freiburg
Country
Germany
Facility Name
Ep0093 368
City
Jena
Country
Germany
Facility Name
Ep0093 366
City
Kehl
Country
Germany
Facility Name
Ep0093 357
City
Leipzig
Country
Germany
Facility Name
Ep0093 353
City
Marburg
Country
Germany
Facility Name
Ep0093 354
City
München
Country
Germany
Facility Name
Ep0093 351
City
Münster
Country
Germany
Facility Name
Ep0093 356
City
Osnabrück
Country
Germany
Facility Name
Ep0093 352
City
Tübingen
Country
Germany
Facility Name
Ep0093 426
City
Thessaloníki
Country
Greece
Facility Name
Ep0093 427
City
Thessaloníki
Country
Greece
Facility Name
Ep0093 400
City
Budapest
Country
Hungary
Facility Name
Ep0093 403
City
Budapest
Country
Hungary
Facility Name
Ep0093 402
City
Debrecen
Country
Hungary
Facility Name
Ep0093 035
City
Cork
Country
Ireland
Facility Name
Ep0093 462
City
Bologna
Country
Italy
Facility Name
Ep0093 450
City
Cagliari
Country
Italy
Facility Name
Ep0093 451
City
Foggia
Country
Italy
Facility Name
Ep0093 461
City
Foggia
Country
Italy
Facility Name
Ep0093 452
City
Milano
Country
Italy
Facility Name
Ep0093 459
City
Pavia
Country
Italy
Facility Name
Ep0093 458
City
Pozzilli
Country
Italy
Facility Name
Ep0093 455
City
Roma
Country
Italy
Facility Name
Ep0093 457
City
Roma
Country
Italy
Facility Name
Ep0093 460
City
Roma
Country
Italy
Facility Name
Ep0093 526
City
Asahikawa
Country
Japan
Facility Name
Ep0093 501
City
Asaka
Country
Japan
Facility Name
Ep0093 521
City
Bunkyō-Ku
Country
Japan
Facility Name
Ep0093 511
City
Fukuoka
Country
Japan
Facility Name
Ep0093 504
City
Hamamatsu
Country
Japan
Facility Name
Ep0093 505
City
Hiroshima
Country
Japan
Facility Name
Ep0093 513
City
Hōfu
Country
Japan
Facility Name
Ep0093 507
City
Itami
Country
Japan
Facility Name
Ep0093 514
City
Kyoto
Country
Japan
Facility Name
Ep0093 512
City
Nagakute
Country
Japan
Facility Name
Ep0093 510
City
Niigata
Country
Japan
Facility Name
Ep0093 515
City
Saitama
Country
Japan
Facility Name
Ep0093 509
City
Shizuoka
Country
Japan
Facility Name
Ep0093 529
City
Yonago
Country
Japan
Facility Name
Ep0093 703
City
Kaunas
Country
Lithuania
Facility Name
Ep0093 702
City
Vilnius
Country
Lithuania
Facility Name
Ep0093 553
City
Culiacán
Country
Mexico
Facility Name
Ep0093 552
City
Mexico
Country
Mexico
Facility Name
Ep0093 601
City
Gdańsk
Country
Poland
Facility Name
Ep0093 607
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Ep0093 605
City
Katowice
Country
Poland
Facility Name
Ep0093 616
City
Katowice
Country
Poland
Facility Name
Ep0093 603
City
Kraków
Country
Poland
Facility Name
Ep0093 614
City
Kraków
Country
Poland
Facility Name
Ep0093 604
City
Lublin
Country
Poland
Facility Name
Ep0093 610
City
Lublin
Country
Poland
Facility Name
Ep0093 606
City
Nowa Sól
Country
Poland
Facility Name
Ep0093 600
City
Poznań
Country
Poland
Facility Name
Ep0093 609
City
Poznań
Country
Poland
Facility Name
Ep0093 602
City
Świdnik
Country
Poland
Facility Name
Ep0093 926
City
Bucuresti
Country
Romania
Facility Name
Ep0093 327
City
Belgrade
Country
Serbia
Facility Name
Ep0093 004
City
Bardejov
Country
Slovakia
Facility Name
Ep0093 662
City
Alicante
Country
Spain
Facility Name
Ep0093 668
City
Barakaldo
Country
Spain
Facility Name
Ep0093 651
City
Barcelona
Country
Spain
Facility Name
Ep0093 652
City
Barcelona
Country
Spain
Facility Name
Ep0093 664
City
Barcelona
Country
Spain
Facility Name
Ep0093 666
City
Córdoba
Country
Spain
Facility Name
Ep0093 658
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Ep0093 656
City
Madrid
Country
Spain
Facility Name
Ep0093 660
City
Madrid
Country
Spain
Facility Name
Ep0093 667
City
Madrid
Country
Spain
Facility Name
Ep0093 674
City
Madrid
Country
Spain
Facility Name
Ep0093 659
City
Málaga
Country
Spain
Facility Name
Ep0093 665
City
Terrassa
Country
Spain
Facility Name
Ep0093 657
City
Valencia
Country
Spain
Facility Name
Ep0093 653
City
Valladolid
Country
Spain
Facility Name
Ep0093 900
City
Istanbul
Country
Turkey
Facility Name
Ep0093 901
City
Istanbul
Country
Turkey
Facility Name
Ep0093 904
City
Istanbul
Country
Turkey
Facility Name
Ep0093 906
City
Istanbul
Country
Turkey
Facility Name
Ep0093 909
City
Istanbul
Country
Turkey
Facility Name
Ep0093 752
City
Birmingham
Country
United Kingdom
Facility Name
Ep0093 766
City
Brighton
Country
United Kingdom
Facility Name
Ep0093 751
City
Swansea
Country
United Kingdom
Facility Name
Ep0093 753
City
Swansea
Country
United Kingdom
Facility Name
Ep0093 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

Learn more about this trial

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

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