Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03739840




Registration number
NCT03739840
Ethics application status
Date submitted
9/11/2018
Date registered
14/11/2018

Titles & IDs
Public title
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Scientific 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
Secondary ID [1] 0 0
2018-002303-33
Secondary ID [2] 0 0
EP0092
Universal Trial Number (UTN)
Trial acronym
DUET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-Resistant Epilepsy 0 0
Focal-Onset Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Padsevonil
Treatment: Drugs - Placebo

Experimental: Padsevonil dosing regimen 1 - Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

Experimental: Padsevonil dosing regimen 2 - Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

Experimental: Padsevonil dosing regimen 3 - Subjects will be randomized to receive a combination of tablets of padsevonil and placebo (as appropriate) to maintain the blinding.

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


Treatment: Drugs: Padsevonil
Padsevonil in different dosages.

Treatment: Drugs: Placebo
Placebo will be provided matching padsevonil.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
Timepoint [1] 0 0
From Baseline over the 12 Week Maintenance Period (up to Week 16)
Primary outcome [2] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
From Baseline until Safety Follow-Up (up to Week 23)
Primary outcome [3] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
Timepoint [3] 0 0
From Baseline until Safety Follow-Up (up to Week 23)
Primary outcome [4] 0 0
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [4] 0 0
From Baseline until Safety Follow-Up (up to Week 23)
Secondary outcome [1] 0 0
75% Responder Rate From Baseline Over the 12-week Maintenance Period
Timepoint [1] 0 0
From Baseline over the 12 Week Maintenance Period (up to Week 16)
Secondary outcome [2] 0 0
50% Responder Rate From Baseline Over the 12-week Maintenance Period
Timepoint [2] 0 0
From Baseline over the 12 Week Maintenance Period (up to Week 16)
Secondary outcome [3] 0 0
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period
Timepoint [3] 0 0
From Baseline over the 12 Week Maintenance Period (up to Week 16)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2020
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ep0092 855 - Box Hill
Recruitment hospital [2] 0 0
Ep0092 861 - Camperdown
Recruitment hospital [3] 0 0
Ep0092 850 - Fitzroy
Recruitment hospital [4] 0 0
Ep0092 853 - Heidelberg
Recruitment hospital [5] 0 0
Ep0092 852 - Melbourne
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Ottignies
Country [23] 0 0
Bosnia and Herzegovina
State/province [23] 0 0
Bihac
Country [24] 0 0
Bosnia and Herzegovina
State/province [24] 0 0
Mostar
Country [25] 0 0
Bosnia and Herzegovina
State/province [25] 0 0
Sarajevo
Country [26] 0 0
Bosnia and Herzegovina
State/province [26] 0 0
Tuzla
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Blagoevgrad
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Pleven
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Croatia
State/province [30] 0 0
Zagreb
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
Country [32] 0 0
Czechia
State/province [32] 0 0
Ostrava
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 5
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha 6
Country [35] 0 0
Denmark
State/province [35] 0 0
Aarhus
Country [36] 0 0
Denmark
State/province [36] 0 0
Odense
Country [37] 0 0
Estonia
State/province [37] 0 0
Tallinn
Country [38] 0 0
Estonia
State/province [38] 0 0
Tartu
Country [39] 0 0
Finland
State/province [39] 0 0
Tampere
Country [40] 0 0
France
State/province [40] 0 0
Lyon
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
France
State/province [42] 0 0
Strasbourg
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Bernau
Country [45] 0 0
Germany
State/province [45] 0 0
Bielefeld
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Jena
Country [48] 0 0
Germany
State/province [48] 0 0
Leipzig
Country [49] 0 0
Germany
State/province [49] 0 0
Regensburg
Country [50] 0 0
Greece
State/province [50] 0 0
Ioánnina
Country [51] 0 0
Greece
State/province [51] 0 0
Thessaloníki
Country [52] 0 0
Hungary
State/province [52] 0 0
Budapest
Country [53] 0 0
Hungary
State/province [53] 0 0
Debrecen
Country [54] 0 0
Hungary
State/province [54] 0 0
Pécs
Country [55] 0 0
Ireland
State/province [55] 0 0
Cork
Country [56] 0 0
Ireland
State/province [56] 0 0
Dublin
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Japan
State/province [58] 0 0
Asahikawa
Country [59] 0 0
Japan
State/province [59] 0 0
Asaka
Country [60] 0 0
Japan
State/province [60] 0 0
Bunkyo-Ku
Country [61] 0 0
Japan
State/province [61] 0 0
Hamamatsu
Country [62] 0 0
Japan
State/province [62] 0 0
Hiroshima
Country [63] 0 0
Japan
State/province [63] 0 0
Hofu
Country [64] 0 0
Japan
State/province [64] 0 0
Itami
Country [65] 0 0
Japan
State/province [65] 0 0
Izumi
Country [66] 0 0
Japan
State/province [66] 0 0
Kumamoto
Country [67] 0 0
Japan
State/province [67] 0 0
Kure
Country [68] 0 0
Japan
State/province [68] 0 0
Kyoto
Country [69] 0 0
Japan
State/province [69] 0 0
Nagakute
Country [70] 0 0
Japan
State/province [70] 0 0
Saitama
Country [71] 0 0
Japan
State/province [71] 0 0
Sapporo
Country [72] 0 0
Japan
State/province [72] 0 0
Shinagawa-Ku
Country [73] 0 0
Japan
State/province [73] 0 0
Shizuoka
Country [74] 0 0
Japan
State/province [74] 0 0
Yonago
Country [75] 0 0
Japan
State/province [75] 0 0
Omura
Country [76] 0 0
Japan
State/province [76] 0 0
Osaka-sayama
Country [77] 0 0
Norway
State/province [77] 0 0
Sandvika
Country [78] 0 0
Poland
State/province [78] 0 0
Katowice
Country [79] 0 0
Poland
State/province [79] 0 0
Kraków
Country [80] 0 0
Poland
State/province [80] 0 0
Lublin
Country [81] 0 0
Poland
State/province [81] 0 0
Nowa Sól
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Poland
State/province [84] 0 0
Zamosc
Country [85] 0 0
Poland
State/province [85] 0 0
Zgierz
Country [86] 0 0
Poland
State/province [86] 0 0
Lódz
Country [87] 0 0
Portugal
State/province [87] 0 0
Aveiro
Country [88] 0 0
Portugal
State/province [88] 0 0
Matosinhos
Country [89] 0 0
Romania
State/province [89] 0 0
Bucuresti
Country [90] 0 0
Romania
State/province [90] 0 0
Târgu-Mures
Country [91] 0 0
Serbia
State/province [91] 0 0
Belgrade
Country [92] 0 0
Serbia
State/province [92] 0 0
Novi Sad
Country [93] 0 0
Slovakia
State/province [93] 0 0
Bardejov
Country [94] 0 0
Spain
State/province [94] 0 0
Alicante
Country [95] 0 0
Spain
State/province [95] 0 0
Barcelona
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
Spain
State/province [98] 0 0
Zaragoza
Country [99] 0 0
Sweden
State/province [99] 0 0
Göteborg
Country [100] 0 0
Sweden
State/province [100] 0 0
Linköping
Country [101] 0 0
Switzerland
State/province [101] 0 0
Zürich
Country [102] 0 0
Turkey
State/province [102] 0 0
Ankara
Country [103] 0 0
Turkey
State/province [103] 0 0
Antalya
Country [104] 0 0
Turkey
State/province [104] 0 0
Istanbul
Country [105] 0 0
Turkey
State/province [105] 0 0
Trabzon
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Brighton
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Manchester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.Vivli.org


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Rademacher M, Toledo M, Van Paesschen W, Liow KK, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03739840