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View Clinical Trial (Medical Research Study)
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Efficacy of YKP3089 in Patients With Photosensitive Epilepsy - NCT00616148-10467 (Clinical Trial 202874)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy202874.aspx
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| City: |
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Bronx, |
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State:
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NY |
| Zip Code: |
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10467 |
| Conditions: |
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Epilepsy |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Montefiore Medical Center
Bronx,, NY 10467
United States
Primary Contact:
Mary Ann Brodie
Email: mbrodie.nyumc@gmail.com
Phone: 212-263-8495 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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