An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Add-on Therapy in Subjects with Partial Onset Seizures
- Conditions
- Partial-onset epilepsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-001859-67-HU
- Lead Sponsor
- SK Life Science, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
1. Male or female and greater than or equal to 18 years of age at the time of signing the informedconsent. The upper age limit is 70 years inclusive.
2. Weightat least40kg
3. Written informed consent signed by the subject or legal guardian prior to entering the study inaccordance with the ICH GCP guidelines. If the written informed consent is provided by thelegal guardian because the subject is unable to do so, a written or verbal assent from thesubjectmust also be obtained. In Germany, only the subject may sign the informed consent form inaccordance with ICH guidelines.
4. A diagnosis of partial epilepsy according to the International League Against Epilepsy’sClassification of Epileptic Seizures. Diagnosis should have been established by clinical historyand an electroencephalogram (EEG) that is consistent with localization related epilepsy; normalinterictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie,clinical history).
5. Have uncontrolled partial seizures and require additional AED therapy despite having beentreated with at leastoneAED within approximately thelast 2 years.
6. Currentlyonstable antiepileptic treatment regimen:
a) Subject must have been receivingstabledoses of 1 to 3AEDs for at least 3 weeks prior to Visit2
b) Vagal nerve stimulator (VNS) or deep brain stimulator (DBS) will not be counted as an AED; however,the parameters must remain stable for at least 4 weeks prior to baseline. The VNS or DBS must have been implanted at least 5 months prior to Visit1.
c) Benzodiazepines taken at least once per week during the 1 month prior to Visit1 for epilepsy, or for anxiety or sleep disorder,will be counted as 1AED and must be continued unchanged throughout the study. Therefore only a maximum of 2 additional approved AEDs will be allowed.
7. Computed tomography (CT)ormagnetic 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 dosing.
8. Ability to reach subject by telephone.
9. Use of an acceptable form of birth control by female subjects of childbearing potential (seeSection7.5).
Any potential exception to inclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the medical monitor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia andsystemic symptoms) or any drug-related rash requiring hospitalization.
2. History of any drug-induced rash or hypersensitivity reaction with documented nature of the rash or Hypersensitivity reaction.
3. History of a first degree relative with a serious cutaneousdrug-inducedadverse reaction.
4. History of serious systemic disease, including hepatic insufficiency, renal insufficiency, amalignant 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
5. Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone
6. Subjects taking concomitant AEDs other than phenytoin or phenobarbital, must not be taking phenytoin or phenobarbital or primidone
7. Subjects with clinical evidence of phenytoin or phenobarbital toxicity
8. A history of nonepileptic or psychogenic seizures
9. Presence of only nonmotor simple partial seizures or primary generalized epilepsies
10. Presence of Lennox-Gastaut syndrome
11. Scheduled epilepsy surgery within 8months after Visit1
12. Subjects planning to have implantation of deep brain stimulator
13. Pregnancy or lactation
14. Any clinically significant laboratory abnormality that in the opinion of the investigator would exclude the subject from the study
15. 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)
16. 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
17. 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
18. Presence ofpsychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recenthistory (within 6 months) of major depressive episode
19. History of alcoholism, drug abuse, or drug addiction within the past 2years
20. Current use of felbamate with less than 18 months of continuous exposure
21. Current or recent (within the past year) use of vigabatrinor ezogabine. Subjects with a priorhistory of treatment with vigabatrin must have documentation showing no evidence of avigabatrin associated clinically significant abnormality in avisual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities withfunduscopic features similar to those seen in retinal pigment dystrophies.
22. History ofstatus epilepticus within 3 months of Visit1
23. Screening laboratory investigation demonstrates abnormal renal function
24. Absolute neutrophilcountless than1500/µL
25. 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 (QTc less than 340 msec
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method