Working… Menu

Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

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. Read our disclaimer for details. Identifier: NCT00616148
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : January 31, 2014
The Epilepsy Study Consortium
Information provided by (Responsible Party):
SK Life Science, Inc.

Brief Summary:
The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: YKP3089 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-induced Paroxysmal EEG-Response: Proof of Principle
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: YKP3089 Drug: YKP3089
Oral dosage form

Primary Outcome Measures :
  1. Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo. [ Time Frame: At the completion of each cohort ]

Secondary Outcome Measures :
  1. Assessment of serum concentrations of concomitant AEDs during administration of YKP3089 as compared to the placebo day. Assessment of safety/tolerability at multiple dose levels. [ Time Frame: At the completion of each cohort ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female age 18-60 years.
  • A diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs.
  • If the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin.
  • A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale (See Section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition.
  • Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
  • A body mass index (BMI) between 18 and 35.
  • Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.

Exclusion Criteria:

  • A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
  • Women who are pregnant or lactating.
  • Women of reproductive potential who do not agree to use effective birth-control methods.
  • Patients taking medications that are known substrates of CYP2B6 and CYP2C19 including but not limited to phenytoin, Phenobarbital, omeprazole, fluvoxamine and efavirenz.
  • Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.
  • An active CNS infection, demyelinating disease, degenerative neurological 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 which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.
  • Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).
  • A history of alcoholism, drug abuse, or drug addiction (within the past 12 months).
  • Patients who would normally be contraindicated for YKP3089 administration.
  • Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.

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 identifier (NCT number): NCT00616148

Layout table for location information
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, New York
Montefiore Medical Center
Bronx,, New York, United States, 10467
Cornell Medical Center
New York, New York, United States, 10021
United States, Pennsylvania
University of Pennsylvania Epilepsy Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
SK Life Science, Inc.
The Epilepsy Study Consortium
Layout table for investigator information
Principal Investigator: Jacqueline French, M.D. NYU MEDICAL CENTER
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SK Life Science, Inc. Identifier: NCT00616148    
Other Study ID Numbers: AA40616
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: December 2013
Keywords provided by SK Life Science, Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases