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 : Enrolling by invitation
First Posted : December 12, 2017
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Drug-Resistant Epilepsy Focal-Onset Seizures||Drug: Padsevonil||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
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.
- Incidence of Treatment-Emergent Adverse Events (TEAEs) reported by the subject 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 2 years) ]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.
- Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal [ Time Frame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to 2 years) ]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.
- Change in log-transformed observable focal-onset seizure frequency from Baseline over the Evaluation Period [ Time Frame: From Baseline in respective parent study over the Evaluation Period (minimum of 2 years) ]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.
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
|Study Director:||UCB Cares||001 844 599 2273 (UCB)|