Multiple Sclerosis Clinical Trial
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Summary
This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term safety.
Full Description
see above
Eligibility Criteria
Inclusion Criteria
Male or female and greater than or equal to 18 years of age at the time of signing the informed consent. The upper age limit is 70 years inclusive.
Weight at least 30 kg
Written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. In Germany, only the subject may sign the informed consent form in accordance with ICH guidelines.
A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history).
Have uncontrolled partial seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
Currently on stable antiepileptic treatment regimen:
Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
Vagal nerve stimulator (VNS) will not be counted as an AED; however, the parameters must remain stable for at least 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1.
Benzodiazepines taken at least once per week during the 1 month prior to Visit 1 for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED and must be continued unchanged throughout the study. Therefore only a maximum of 2 additional approved AEDs will be allowed.
Computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within the past 10 years that ruled out a progressive cause of epilepsy. If a CT or MRI has not been performed within the past 10 years, one must be performed prior to randomization.
Ability to reach subject by telephone.
Use of an acceptable form of birth control by female subjects of childbearing potential
Exclusion Criteria
History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization.
History of any drug-induced rash or hypersensitivity reaction.
History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
History of serious systemic disease, including hepatic insufficiency, renal insufficiency, a malignant neoplasm, any disorder in which prognosis for survival is less than 3 months, or any disorder which in the judgment of the investigator will place the subject at excessive risk by participation in a controlled trial
Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone
Subjects taking concomitant AEDs other than phenytoin or phenobarbital, must not be taking phenytoin or phenobarbital or primidone
Subjects with clinical evidence of phenytoin or phenobarbital toxicity
A history of nonepileptic or psychogenic seizures
Presence of only nonmotor simple partial seizures or primary generalized epilepsies
Presence of Lennox-Gastaut syndrome
Scheduled epilepsy surgery within 8 months after Visit 1
Subjects implanted with or planning to have implantation of deep brain stimulator
Pregnancy or lactation
Any clinically significant laboratory abnormality that in the opinion of the investigator would exclude the subject from the study
Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal (ULN)
An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study
Presence of psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recent history (within 6 months) of major depressive episode
History of alcoholism, drug abuse, or drug addiction within the past 2 years
Current use of felbamate with less than 18 months of continuous exposure
Current or recent (within the past year) use of vigabatrin or ezogabine. Subjects with a prior history of treatment with vigabatrin must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies.
History of status epilepticus within 3 months of Visit 1
Screening laboratory investigation demonstrates abnormal renal function
Absolute neutrophil count less than 1500/µL
Clinical or ECG evidence of serious cardiac disease, including ischemic heart disease, uncontrolled heart failure, and major arrhythmias, or relevant replicated changes in QT intervals (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females)
Platelet counts lower than 80,000/µL in subjects treated with VPA
A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years.
More than 1 lifetime suicide attempt
Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
Current use of any of the following medications: clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, fosphenytoin, ethotoin, mephenytoin, or natural progesterone (within 1 month of Visit 1)
History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV
Presence of congenital short QT syndrome
A history of previous exposure to YKP3089
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There are 114 Locations for this study
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85006, United States
Little Rock Arkansas, 72205, United States
Anaheim California, 92806, United States
Fresno California, 93710, United States
San Francisco California, 94115, United States
Englewood Colorado, 80113, United States
Bradenton Florida, 34205, United States
Gulf Breeze Florida, 32561, United States
Atlanta Georgia, 30329, United States
Suwanee Georgia, 30024, United States
Honolulu Hawaii, 96814, United States
Boise Idaho, 83702, United States
Ames Iowa, 50010, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20817, United States
Waldorf Maryland, 20603, United States
Minneapolis Minnesota, 55422, United States
Chesterfield Missouri, 63017, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78758, United States
Greenville Texas, 75034, United States
Temple Texas, 76508, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98104, United States
Seattle Washington, 98122, United States
Madison Wisconsin, 53715, United States
Buenos Aires Ciudad Autónoma De BuenosAires, C1431, Argentina
Buenos Aires , C1093, Argentina
Buenos Aires , C1093, Argentina
Bedford Park , 5042, Australia
Box Hill , 3128, Australia
Camperdown , 2050, Australia
Chatswood , 2067, Australia
Clayton , 3168, Australia
Fitzroy , 3065, Australia
Heidelberg , 3084, Australia
Herston , 4029, Australia
Melbourne , 3004, Australia
Parkville , 3050, Australia
Randwick , 2031, Australia
Westmead , 2145, Australia
Blagoevgrad , 2700, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1142, Bulgaria
Sofia , 1431, Bulgaria
La Florida Santiago, 82600, Chile
Puente Alto Santiago, 82072, Chile
Valdivia , 50901, Chile
Brno , 656 9, Czechia
Prague , 148 0, Czechia
Praha 5 , 150 0, Czechia
Bielefeld , 33617, Germany
Bonn , 53123, Germany
Kehl , 77694, Germany
Mainz , 55131, Germany
Marburg , 35043, Germany
Münster , 48149, Germany
Budapest , 1145, Hungary
Debrecen , 4031, Hungary
Kecskemét , 6000, Hungary
Busan , 602-7, Korea, Republic of
Daegu , 41931, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 11074, Korea, Republic of
Seoul , 13873, Korea, Republic of
Seoul , 143-7, Korea, Republic of
Ciudad de Mexico , 03310, Mexico
Ciudad de Mexico , 14200, Mexico
Culiacán , 80020, Mexico
Monterrey , 64060, Mexico
Tlanepantla De Baz , 54055, Mexico
Åódź Lódzkie, 90-32, Poland
Kraków Malopolski, 31-20, Poland
Warszawa Mazowieckie, 02-95, Poland
Warszawa Mazowieckie, 02-95, Poland
Katowice Slaskie, 40-65, Poland
Gdańsk , 80-80, Poland
Moscow , 11999, Russian Federation
Perm , 61499, Russian Federation
Saint Petersburg , 19201, Russian Federation
Saint Petersburg , 19737, Russian Federation
Samara , 44309, Russian Federation
Smolensk , 21401, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Badalona , 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Granada , 18016, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Göteborg , SE-41, Sweden
Chiang Mai Muang, 50200, Thailand
Bangkok Pathumwan, 10330, Thailand
Dnipro , 49005, Ukraine
Kharkiv , 61068, Ukraine
Kharkiv , 61103, Ukraine
Lviv , 79010, Ukraine
Odesa , , Ukraine
Odesa , , Ukraine
Oleksandrivka , 67513, Ukraine
Ternopil , 46027, Ukraine
Vinnytsia , 21005, Ukraine
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