Clinical trial NCT00616148 (phase 2, status: completed)
Conditions: epilepsy
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: ykp3089, placebo
SMILES: NC(=O)O[C@@H](CN1N=CN=N1)C1=CC=CC=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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.