Drug-Resistant EpilepsyPhase 2NCT03370120
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
A Phase 2 study testing Padsevonil in people with Drug-Resistant Epilepsy and Focal-Onset Seizures, run by UCB Biopharma SRL at 156 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Resistant Epilepsy, Focal-Onset Seizures
- What is being tested?
- Padsevonil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 156 sitesin 27 countries
- Study dates
- 27 Aug 2018to 11 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Subjects will be withdrawn from the study as soon as pregnancy is known.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.
Who cannot join
- 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
Trial locations and contacts
156 sites in 27 countries.
156 sites in 27 countries
United States25 sites
Ep0093 805
Austin, Texas, 78701
Ep0093 844
Austin, Texas, 78758
Ep0093 822
Baltimore, Maryland, 21287
Ep0093 818
Bethesda, Maryland, 20817
Ep0093 889
Boston, Massachusetts, 02215
Ep0093 839
Chandler, Arizona, 85226
Ep0093 890
Chapel Hill, North Carolina, 27514
Ep0093 884
Charlotte, North Carolina, 28204
Ep0093 642
Columbia, Ohio, 43210
Ep0093 838
Cordova, Tennessee, 38018
Ep0093 638
Fort Wayne, Indiana, 46804
Ep0093 645
Golden Valley, Minnesota, 55422
Ep0093 806
Hackensack, New Jersey, 07601
Ep0093 803
Honolulu, Hawaii, 96817
Ep0093 815
La Jolla, California, 92037
Ep0093 707
Lexington, Kentucky, 40536
Ep0093 835
Nashville, Tennessee, 37232
Ep0093 802
Philadelphia, Pennsylvania, 19107
Ep0093 639
Renton, Washington, 98055
Ep0093 824
Round Rock, Texas, 78681
Ep0093 817
Saint Paul, Minnesota, 55102
Ep0093 870
San Antonio, Texas, 78229
Ep0093 801
San Francisco, California, 94115
Ep0093 893
Syracuse, New York, 13210
Ep0093 895
The Bronx, New York, 10467-24 01
Spain15 sites
Ep0093 662
Alicante
Ep0093 668
Barakaldo
Ep0093 651
Barcelona
Ep0093 652
Barcelona
Ep0093 664
Barcelona
Ep0093 666
Córdoba
Ep0093 658
L'Hospitalet de Llobregat
Ep0093 656
Madrid
Ep0093 660
Madrid
Ep0093 667
Madrid
Ep0093 674
Madrid
Ep0093 659
Málaga
Ep0093 665
Terrassa
Ep0093 657
Valencia
Ep0093 653
Valladolid
Germany14 sites
Ep0093 365
Berlin
Ep0093 362
Bernau
Ep0093 363
Bielefeld
Ep0093 358
Bonn
Ep0093 350
Frankfurt
Ep0093 360
Freiburg im Breisgau
Ep0093 368
Jena
Ep0093 366
Kehl
Ep0093 357
Leipzig
Ep0093 353
Marburg
Ep0093 354
München
Ep0093 351
Münster
Ep0093 356
Osnabrück
Ep0093 352
Tübingen
Japan14 sites
Ep0093 526
Asahikawa
Ep0093 501
Asaka
Ep0093 521
Bunkyō City
Ep0093 511
Fukuoka
Ep0093 504
Hamamatsu
Ep0093 505
Hiroshima
Ep0093 513
Hōfu
Ep0093 507
Itami
Ep0093 514
Kyoto
Ep0093 512
Nagakute
Ep0093 510
Niigata
Ep0093 515
Saitama
Ep0093 509
Shizuoka
Ep0093 529
Yonago
Poland12 sites
Ep0093 601
Gdansk
Ep0093 607
Grodzisk Mazowiecki
Ep0093 605
Katowice
Ep0093 616
Katowice
Ep0093 603
Krakow
Ep0093 614
Krakow
Ep0093 604
Lublin
Ep0093 610
Lublin
Ep0093 606
Nowa Sól
Ep0093 600
Poznan
Ep0093 609
Poznan
Ep0093 602
Świdnik
Italy10 sites
Ep0093 462
Bologna
Ep0093 450
Cagliari
Ep0093 451
Foggia
Ep0093 461
Foggia
Ep0093 452
Milan
Ep0093 459
Pavia
Ep0093 458
Pozzilli
Ep0093 455
Roma
Ep0093 457
Roma
Ep0093 460
Roma
Australia8 sites
Ep0093 855
Box Hill
Ep0093 857
Clayton
Ep0093 850
Fitzroy
Ep0093 853
Heidelberg
Ep0093 859
Herston
Ep0093 852
Melbourne
Ep0093 856
Randwick
Ep0093 854
Westmead
Bulgaria7 sites
Ep0093 150
Blagoevgrad
Ep0093 151
Pleven
Ep0093 153
Pleven
Ep0093 156
Pleven
Ep0093 152
Sofia
Ep0093 154
Sofia
Ep0093 155
Sofia
France6 sites
Ep0093 307
Clermont-Ferrand
Ep0093 309
Dijon
Ep0093 300
Lille
Ep0093 302
Montpellier
Ep0093 303
Rennes
Ep0093 301
Strasbourg
Belgium5 sites
Ep0093 102
Bruges
Ep0093 101
Brussels
Ep0093 105
Ghent
Ep0093 100
Leuven
Ep0093 107
Ottignies
Czechia5 sites
Ep0093 254
Brno
Ep0093 255
Ostrava
Ep0093 250
Prague
Ep0093 251
Prague
Ep0093 253
Prague
Turkey (Türkiye)5 sites
Ep0093 900
Istanbul
Ep0093 901
Istanbul
Ep0093 904
Istanbul
Ep0093 906
Istanbul
Ep0093 909
Istanbul
United Kingdom5 sites
Ep0093 752
Birmingham
Ep0093 766
Brighton
Ep0093 751
Swansea
Ep0093 753
Swansea
Ep0093 764
Swansea
Bosnia and Herzegovina2 sites
Ep0093 075
Sarajevo
Ep0093 082
Tuzla
About this study
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
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.
- Conditions
- Drug-Resistant Epilepsy, Focal-Onset Seizures
- Being tested
- Padsevonil
- Keywords
- Drug-Resistant Epilepsy, Padsevonil
- Medical subject headings
- Drug Resistant Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PadsevonilDrug
- Pharmaceutical Form: film-coated tablet
- Route of Administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Padsevonil | Experimental | 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. Receives: Drug: Padsevonil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
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.
Measured: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
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.
Measured: From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start27 Aug 2018
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Why it stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug-Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370120
- Sponsor's protocol ID
- EP0093
- Other IDs
- 2017-003241-26, 2017
- Status last verified
- Nov 2021
- First submitted
- 7 Dec 2017
- Last updated
- 29 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03370120
- Acronym / sponsor ID
- EP0093
- Conditions
- Drug-Resistant Epilepsy, Focal-Onset Seizures
- Keywords
- Drug-Resistant Epilepsy, Padsevonil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
- Enrolment
- 406 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 29 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Padsevonil | Experimental | Drug: PadsevonilPadsevonil 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Padsevonil* Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use | Drug | Padsevonil |
Primary outcome
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
Time frame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
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
Time frame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
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
Time frame: From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
156 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Padsevonil in people with Drug-Resistant Epilepsy and Focal-Onset Seizures, run by UCB Biopharma SRL at 156 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 156 sites in United States, Spain, Germany, Japan, Poland and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.