Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

Epilepsy Clinical Trial

Official title:

Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-induced Paroxysmal EEG-Response: Proof of Principle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616148
• Other study ID #: AA40616
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2008
• Last updated: December 26, 2013
• Start date: August 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2013
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• YKP3089
Oral dosage form
• Placebo

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx,	New York
United States	Cornell Medical Center	New York	New York
United States	University of Pennsylvania Epilepsy Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SK Life Science	The Epilepsy Study Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo.		At the completion of each cohort	No
Secondary	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	Yes