Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

Sponsor

SK Life Science, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00616148

Collaborator

The Epilepsy Study Consortium (Other)

Enrollment

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

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 :

Aug 1, 2007

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Experimental: YKP3089

Drug: YKP3089

Oral dosage form

Outcome Measures

Primary Outcome Measures

Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo. [At the completion of each cohort]

Secondary Outcome Measures

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. [At the completion of each cohort]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Johns Hopkins Medical Center	Baltimore	Maryland	United States	21287
2	Montefiore Medical Center	Bronx,	New York	United States	10467
3	Cornell Medical Center	New York	New York	United States	10021
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SK Life Science, Inc.

ClinicalTrials.gov Identifier:

NCT00616148

Other Study ID Numbers:

AA40616

First Posted:

Feb 15, 2008

Last Update Posted:

Jan 31, 2014

Last Verified:

Dec 1, 2013

Keywords provided by SK Life Science, Inc.

Epilepsy

Seizures

Additional relevant MeSH terms:

Epilepsy

Cenobamate

Study Results

No Results Posted as of Jan 31, 2014