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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02535091




Registration number
NCT02535091
Ethics application status
Date submitted
21/08/2015
Date registered
28/08/2015
Date last updated
22/02/2019

Titles & IDs
Public title
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Scientific title
An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Secondary ID [1] 0 0
YKP3089C021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YKP3089

Experimental: YKP3089 - Multiple dose


Treatment: Drugs: YKP3089
see above

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the pharmacokinetics of YKP3089 and concomitant Antiepileptic Drugs (AEDs) - Change from baseline of trough plasma concentrations of YKP3089 and concomitant AEDs
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - All observed or volunteered AEs and SAEs regardless of suspected causal relationship to the investigational product to be reported
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Hematology) - Hematology data will be analyzed by central laboratories.
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Chemistry) - Chemistry data will be analyzed by central laboratories
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) - Urinalysis data will be analyzed by central laboratories
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Percentage of Participants With Vital Sign Results of Potential Clinical Importance - Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance to be determined according to investigator clinical judgement
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Strategic Health Evaluators - Chatswood
Recruitment hospital [5] 0 0
Monash Medical Centre Clayton Campus - Clayton
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [11] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
- Chatswood
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
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United States of America
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Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
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Oregon
Country [18] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
Country [20] 0 0
United States of America
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Tennessee
Country [21] 0 0
United States of America
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Texas
Country [22] 0 0
United States of America
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Virginia
Country [23] 0 0
United States of America
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Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
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Buenos Aires
Country [26] 0 0
Argentina
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La Plata
Country [27] 0 0
Bulgaria
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Blagoevgrad
Country [28] 0 0
Bulgaria
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Sofia
Country [29] 0 0
Chile
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Puente Alto
Country [30] 0 0
Chile
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Santiago
Country [31] 0 0
Chile
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Valdivia
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Czechia
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Brno
Country [33] 0 0
Czechia
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Prague
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Czechia
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Praha 5
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Germany
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Bielefeld
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Germany
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Bonn
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Germany
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Kehl
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Germany
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Mainz
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Germany
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Marburg
Country [40] 0 0
Germany
State/province [40] 0 0
Münster
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Hungary
State/province [42] 0 0
Debrecen
Country [43] 0 0
Hungary
State/province [43] 0 0
Kecskemét
Country [44] 0 0
Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Ciudad de mexico
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Mexico
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Culiacán
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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Tlanepantla De Baz
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Poland
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Gdansk
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Katowice
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Kraków
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Poland
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Warszawa
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Poland
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Lódz
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Russian Federation
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Moscow
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Russian Federation
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Perm
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Russian Federation
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Saint Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Samara
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Smolensk
Country [62] 0 0
Serbia
State/province [62] 0 0
Belgrade
Country [63] 0 0
Serbia
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Kragujevac
Country [64] 0 0
Spain
State/province [64] 0 0
Badalona
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Spain
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Barcelona
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Spain
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Granada
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Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Valencia
Country [69] 0 0
Sweden
State/province [69] 0 0
Göteborg
Country [70] 0 0
Ukraine
State/province [70] 0 0
Dnipropetrovsk
Country [71] 0 0
Ukraine
State/province [71] 0 0
Kharkiv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Lviv
Country [73] 0 0
Ukraine
State/province [73] 0 0
Odesa
Country [74] 0 0
Ukraine
State/province [74] 0 0
Oleksandrivka
Country [75] 0 0
Ukraine
State/province [75] 0 0
Ternopil
Country [76] 0 0
Ukraine
State/province [76] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SK Life Science, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02535091
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leona Borchert, MD
Address 0 0
SK Life Science, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications