Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Partial Epilepsy Clinical Trial

Official title:

A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397968
• Other study ID #: YKP3089C013
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2011
• Est. completion date: January 28, 2021

Study information

• Verified date: April 2022
• Source: SK Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: January 28, 2021
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of treatment resistant partial epilepsy;
• History of epilepsy for at least 2 years;
• Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
• Currently treated on a stable dose of :
• 1 - 3 AED's for at least 12 weeks prior to randomization.
• VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
• Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.

2. Subject has had status epilepticus within past 1 year.

3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.

4. Subjects taking felbamate with less than 18 months continuous exposure.

5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.

6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.

7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.

8. Subject meets criteria for current major depressive episode (within 6 months).

9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsy
• Seizures

Intervention

Drug:
• YKP3089
Capsule, dose to be titrated Tablet, dose to be titrated
• Placebo
Placebo capsule Placebo tablet

Locations

Country	Name	City	State
India	Bangalore Clinisearch	Bangalore	Karnataka
India	M.S. Ramaiah Medical College and Hospital	Bangalore	Karnataka
India	St. Theresa's General Hospital	Hyderabad	Andhra Pradesh
India	Nightingale Hospital	Kolkata	West Bengal
India	Mallikatta Neuro Centre	Mangalore	Karnataka
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Max Super Specialty Hospital	Saket	New Delhi
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	NZOZ Vito-Med Sp. Zo.o	Gliwice
Poland	NZOZ Diagnomed	Katowice
Poland	SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca	Katowice
Poland	Centrum Leczenia Padaczki i Migreny	Krakow
Poland	Malopolskie Centrum Medyczne	Krakow
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Solumed s.c.	Poznan
United States	Kaiser Permanente	Anaheim	California
United States	John's Hopkins University School of Medicine	Baltimore	Maryland
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	University of Virginia	Charlottesville	Virginia
United States	Suite 209 South	Chesterfield	Missouri
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Neurological Clinic of Texas, P.A.	Dallas	Texas
United States	Bluegrass Epilepsy Research, LLC	Lexington	Kentucky
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Thomas Jefferson University Comprehensive Epilepsy Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	St. Joseph Hospital & Medical Center/Barrow Neurology Clinic	Phoenix	Arizona
United States	The University of Toledo	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science, Inc.

Countries where clinical trial is conducted

United States,  India,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline	assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Secondary	50% Responder Rate	Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.	12 weeks