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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03373383




Registration number
NCT03373383
Ethics application status
Date submitted
7/12/2017
Date registered
14/12/2017

Titles & IDs
Public title
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
Scientific 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
Secondary ID [1] 0 0
2017-003200-48
Secondary ID [2] 0 0
EP0091
Universal Trial Number (UTN)
Trial acronym
ARISE
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
Other interventions - 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.

Experimental: Padsevonil dosing regimen 4 - 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.

Other interventions: Placebo
Placebo will be provided matching Padsevonil.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
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
Primary outcome [2] 0 0
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
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) During the Entire Study
Timepoint [4] 0 0
From Baseline until Safety Follow-Up (up to Week 23)
Secondary outcome [1] 0 0
75 % Responder Rate Over the 12 Week Maintenance Period
Timepoint [1] 0 0
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
Secondary outcome [2] 0 0
50 % Responder Rate Over the 12 Week Maintenance Period
Timepoint [2] 0 0
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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
End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2020
Sample size
Target
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ep0091 855 - Box Hill
Recruitment hospital [2] 0 0
Ep0091 857 - Clayton
Recruitment hospital [3] 0 0
Ep0091 850 - Fitzroy
Recruitment hospital [4] 0 0
Ep0091 859 - Herston
Recruitment hospital [5] 0 0
Ep0091 852 - Melbourne
Recruitment hospital [6] 0 0
Ep0091 853 - Melbourne
Recruitment hospital [7] 0 0
Ep0091 856 - Randwick
Recruitment hospital [8] 0 0
Ep0091 854 - Westmead
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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District of Columbia
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Maryland
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Minnesota
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New Jersey
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New York
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Pennsylvania
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Tennessee
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Texas
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Canada
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Greenfield Park
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Bernau
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Bielefeld
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Strausberg
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Tübingen
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Debrecen
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Pavia
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Pozzilli
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Reggio Calabria
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Roma
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Bardejov
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Hlohovec
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Alicante
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Barcelona
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Bilbao
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Madrid
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Málaga
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Sevilla
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Terrassa
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Valencia
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Valladolid
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Turkey
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Eskisehir
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Turkey
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Istanbul
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Inverness
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London
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United Kingdom
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Manchester
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma S.P.R.L.
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



Results are available at https://clinicaltrials.gov/study/NCT03373383