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Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

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

February 4, 2008
February 15, 2008
January 31, 2014
August 2007
January 2009   (Final data collection date for primary outcome measure)
Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo. [ Time Frame: At the completion of each cohort ]
Same as current
Complete list of historical versions of study NCT00616148 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of YKP3089 in Patients With Photosensitive Epilepsy
Pharmacodynamic Evaluation of YKP3089 in Epilepsy Patients With a Photo-induced Paroxysmal EEG-Response: Proof of Principle
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Epilepsy
  • Drug: YKP3089
    Oral dosage form
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: YKP3089
    Intervention: Drug: YKP3089
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
12
January 2010
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00616148
AA40616
Yes
Not Provided
Not Provided
SK Life Science
SK Life Science
The Epilepsy Study Consortium
Principal Investigator: Jacqueline French, M.D. NYU MEDICAL CENTER
SK Life Science
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP