Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

• ClinicalTrials.gov Identifier: NCT00616148
• Recruitment Status: Completed
• First Posted: February 15, 2008
• Last Update Posted: January 31, 2014
• Sponsor: SK Life Science, Inc.
• Collaborator: The Epilepsy Study Consortium
• Information provided by (Responsible Party): SK Life Science, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Jacqueline French, M.D.; NYU MEDICAL CENTER

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kasteleijn-Nolst Trenite DGA, DiVentura BD, Pollard JR, Krauss GL, Mizne S, French JA. Suppression of the photoparoxysmal response in photosensitive epilepsy with cenobamate (YKP3089). Neurology. 2019 Aug 6;93(6):e559-e567. doi: 10.1212/WNL.0000000000007894. Epub 2019 Jul 10.

• Responsible Party: SK Life Science, Inc.
• ClinicalTrials.gov Identifier: NCT00616148
• Other Study ID Numbers: AA40616
• First Posted: February 15, 2008
• Last Update Posted: January 31, 2014
• Last Verified: December 2013

Keywords provided by SK Life Science, Inc.:

Epilepsy; Seizures

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases