Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
NCT ID: NCT03373383
Last Updated: 2023-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
411 participants
INTERVENTIONAL
2018-02-12
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Padsevonil dosing regimen 1
Subjects will be randomized to receive a combination of tablets of Padsevonil and Placebo (as appropriate) to maintain the blinding.
Padsevonil
Padsevonil in different dosages.
Placebo
Placebo will be provided matching Padsevonil.
Padsevonil dosing regimen 2
Subjects will be randomized to receive a combination of tablets of Padsevonil and Placebo (as appropriate) to maintain the blinding.
Padsevonil
Padsevonil in different dosages.
Placebo
Placebo will be provided matching Padsevonil.
Padsevonil dosing regimen 3
Subjects will be randomized to receive a combination of tablets of Padsevonil and Placebo (as appropriate) to maintain the blinding.
Padsevonil
Padsevonil in different dosages.
Placebo
Placebo will be provided matching Padsevonil.
Padsevonil dosing regimen 4
Subjects will be randomized to receive a combination of tablets of Padsevonil and Placebo (as appropriate) to maintain the blinding.
Padsevonil
Padsevonil in different dosages.
Placebo
Placebo will be provided matching Padsevonil.
Placebo
Subjects randomized to the placebo group will receive a combination of several Placebo tablets to maintain the blinding.
Placebo
Placebo will be provided matching Padsevonil.
Interventions
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Padsevonil
Padsevonil in different dosages.
Placebo
Placebo will be provided matching Padsevonil.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Ep0091 839
Chandler, Arizona, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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San Francisco, California, United States
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Washington D.C., District of Columbia, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Peoria, Illinois, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Saint Paul, Minnesota, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Cordova, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Box Hill, , Australia
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Clayton, , Australia
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Fitzroy, , Australia
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Herston, , Australia
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Melbourne, , Australia
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Melbourne, , Australia
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Randwick, , Australia
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Westmead, , Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Blagoevgrad, , Bulgaria
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Pleven, , Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Greenfield Park, , Canada
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London, , Canada
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Montreal, , Canada
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Brno, , Czechia
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Ostrava-Poruba, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Clermont-Ferrand, , France
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Dijon, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Bad Neustadt an der Saale, , Germany
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Berlin, , Germany
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Bernau, , Germany
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Bielefeld, , Germany
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Bonn, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Kork, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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München, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Ravensburg, , Germany
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Strausberg, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Bologna, , Italy
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Cagliari, , Italy
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Foggia, , Italy
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Milan, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pozzilli, , Italy
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Reggio Calabria, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Asaka, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hōfu, , Japan
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Itami, , Japan
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Kodaira, , Japan
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Kyoto, , Japan
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Nagakute, , Japan
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Niigata, , Japan
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Saitama, , Japan
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Shizuoka, , Japan
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Culiacán, , Mexico
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Mexico City, , Mexico
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Gdansk, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Nowa Sól, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Świdnik, , Poland
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Santa Maria da Feira, , Portugal
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Bardejov, , Slovakia
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Hlohovec, , Slovakia
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Terrassa, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Eskişehir, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Inverness, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003200-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP0091
Identifier Type: -
Identifier Source: org_study_id