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Trial record 1 of 1 for:    NCT03370120
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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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370120
Recruitment Status : Terminated (Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure)
First Posted : December 12, 2017
Results First Posted : December 29, 2021
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug-Resistant Epilepsy Focal-Onset Seizures Drug: Padsevonil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : December 11, 2020
Actual Study Completion Date : December 11, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Padsevonil

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.

 Drug: Padsevonil
  • Pharmaceutical Form: film-coated tablet
  • Route of Administration: Oral use


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370120


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Study Protocol  [PDF] February 4, 2020
Statistical Analysis Plan  [PDF] September 25, 2020

More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT03370120    
Other Study ID Numbers: EP0093
2017-003241-26 ( EudraCT Number )
First Posted: December 12, 2017    Key Record Dates
Results First Posted: December 29, 2021
Last Update Posted: December 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: http://www.Vivli.org

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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
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Drug-Resistant Epilepsy
Padsevonil
Additional relevant MeSH terms:
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Epilepsy
Seizures
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Padsevonil
Anticonvulsants