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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
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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
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Secondary ID [1]
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2017-003200-48
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Secondary ID [2]
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EP0091
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Universal Trial Number (UTN)
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Trial acronym
ARISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Drug-resistant Epilepsy
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Focal-Onset Seizures
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline over the 12 Week Maintenance Period
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Primary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline until Safety Follow-Up (up to Week 23)
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Primary outcome [3]
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
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Assessment method [3]
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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.
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Timepoint [3]
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From Baseline until Safety Follow-Up (up to Week 23)
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Primary outcome [4]
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Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study
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Assessment method [4]
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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.
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Timepoint [4]
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From Baseline until Safety Follow-Up (up to Week 23)
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Secondary outcome [1]
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75 % Responder Rate Over the 12 Week Maintenance Period
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Assessment method [1]
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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.
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Timepoint [1]
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End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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Secondary outcome [2]
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50 % Responder Rate Over the 12 Week Maintenance Period
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Assessment method [2]
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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.
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Timepoint [2]
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End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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Secondary outcome [3]
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Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period
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Assessment method [3]
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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.
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Timepoint [3]
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End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/01/2020
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Sample size
Target
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Accrual to date
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Final
411
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ep0091 855 - Box Hill
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Ep0091 857 - Clayton
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Ep0091 850 - Fitzroy
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Ep0091 859 - Herston
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Ep0091 852 - Melbourne
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Ep0091 853 - Melbourne
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Ep0091 856 - Randwick
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Ep0091 854 - Westmead
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Recruitment postcode(s) [1]
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- Box Hill
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- Clayton
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- Fitzroy
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- Herston
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- Melbourne
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- Randwick
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Recruitment postcode(s) [7]
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- Westmead
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Recruitment outside Australia
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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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United Kingdom
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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
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma S.P.R.L.
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03373383
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Trial related presentations / publications
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. Kramer H, Bicer C, Otoul C, Rospo C, Macpherson M, Watling M, Bani M, Sciberras D, Chanteux H. Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development. AAPS J. 2023 Nov 16;26(1):1. doi: 10.1208/s12248-023-00866-7.
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Public notes
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Contacts
Principal investigator
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UCB Cares
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001 844 599 2273 (UCB)
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.Vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/83/NCT03373383/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/83/NCT03373383/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Rademacher M, Toledo M, Van Paesschen W, Liow KK, ...
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Journal
Kramer H, Bicer C, Otoul C, Rospo C, Macpherson M,...
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Results are available at
https://clinicaltrials.gov/study/NCT03373383