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Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

This study is currently recruiting participants.
Verified June 2017 by SK Life Science
Sponsor:
ClinicalTrials.gov Identifier:
NCT02535091
First Posted: August 28, 2015
Last Update Posted: June 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
SK Life Science
  Purpose
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.

Condition Intervention Phase
Partial Epilepsy Drug: YKP3089 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Evaluate the pharmacokinetics of YKP3089 and concomitant Antiepileptic Drugs (AEDs) [ Time Frame: 12 months ]
    Change from baseline of trough plasma concentrations of YKP3089 and concomitant AEDs

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 12 months ]
    All observed or volunteered AEs and SAEs regardless of suspected causal relationship to the investigational product to be reported

  • Percentage of Participants With Laboratory Test Abnormalities (Hematology) [ Time Frame: 12 months ]
    Hematology data will be analyzed by central laboratories.

  • Percentage of Participants With Laboratory Test Abnormalities (Chemistry) [ Time Frame: 12 months ]
    Chemistry data will be analyzed by central laboratories

  • Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) [ Time Frame: 12 months ]
    Urinalysis data will be analyzed by central laboratories

  • Percentage of Participants With Vital Sign Results of Potential Clinical Importance [ Time Frame: 12 months ]
    Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance to be determined according to investigator clinical judgement


Estimated Enrollment: 1200
Study Start Date: July 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YKP3089 Adjunctive Therapy Drug: YKP3089

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  2. Weight at least 30 kg
  3. 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.
  4. 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).
  5. Have uncontrolled partial seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
  6. Currently on stable antiepileptic treatment regimen:

    1. Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
    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.
    3. 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.
  7. 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.
  8. Ability to reach subject by telephone.
  9. Use of an acceptable form of birth control by female subjects of childbearing potential

Exclusion Criteria

  1. 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.
  2. History of any drug-induced rash or hypersensitivity reaction.
  3. History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
  4. 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
  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 8 months after Visit 1
  12. Subjects implanted with or 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 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
  19. History of alcoholism, drug abuse, or drug addiction within the past 2 years
  20. Current use of felbamate with less than 18 months of continuous exposure
  21. 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.
  22. History of status epilepticus within 3 months of Visit 1
  23. Screening laboratory investigation demonstrates abnormal renal function
  24. Absolute neutrophil count less than 1500/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 (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females)
  26. Platelet counts lower than 80,000/µL in subjects treated with VPA
  27. 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.
  28. More than 1 lifetime suicide attempt
  29. Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
  30. 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)
  31. History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV
  32. Presence of congenital short QT syndrome
  33. A history of previous exposure to YKP3089
  Contacts and Locations
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): NCT02535091


Contacts
Contact: Eva Pietras, MS 201-421-3887 eva@sk.com
Contact: Jessica Kim, PharmD 201-421-3843 jessicak@sk.com

  Show 101 Study Locations
Sponsors and Collaborators
SK Life Science
  More Information

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT02535091     History of Changes
Other Study ID Numbers: YKP3089C021
First Submitted: August 21, 2015
First Posted: August 28, 2015
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Seizures
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms