The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Exclusion Criteria

• •1. Pregnant or lactating women.
• •2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum B-HCG test at the initial screening visit (Visit 1), and a negative urine pregnancy test at the Baseline visit (Visit 3). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator.
• •3. Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception.
• •4. Patients with a past or present history of drug or alcohol abuse as per DSM IV criteria.
• •5. Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to the baseline visit. Use of anti-psychotic medication including clozapine and quetiapine is prohibited even if the indication is for movement disorders.
• •6. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
• •7. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
• •8. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
• •9. Patients with current or prior treatment (within 4 weeks prior to the baseline visit) with medication known to induce the enzyme cytochrome P450 3A4.
• •10. Current or prior treatment (within 4 weeks prior to the baseline visit) with tolcapone, methyldopa, budipine, reserpine, seroquel or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
• •11. Patients with previous stereotactic surgery (eg pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
• •12. Patients receiving or with planned (next 6 months) deep brain stimulation.
• •13. Patients who have received an investigational product within 4 weeks prior to the screening visit or patients that have participated in a previous study with E2007.
• •14. Patients with clinically significant cognitive impairment (MMSE \<24 and /or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
• •15. Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
• •16. Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.