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Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

This study has been completed.
Sponsor:
Collaborator:
The Epilepsy Study Consortium
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00616148
First received: February 4, 2008
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Epilepsy
Drug: YKP3089
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-induced Paroxysmal EEG-Response: Proof of Principle

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo. [ Time Frame: At the completion of each cohort ] [ Designated as safety issue: No ]

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. [ Time Frame: At the completion of each cohort ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: August 2007
Study Completion Date: January 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: YKP3089 Drug: YKP3089
Oral dosage form

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616148

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
The Epilepsy Study Consortium
Investigators
Principal Investigator: Jacqueline French, M.D. NYU MEDICAL CENTER
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00616148     History of Changes
Other Study ID Numbers: AA40616
Study First Received: February 4, 2008
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
Epilepsy
Seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014