A Study of E2007 as an Adjunctive Therapy 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 or urine B-HCG test at their first study visit. 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. Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per DSM IV criteria.
• •4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
• •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 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.
• •7. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
• •8. Medication known to induce the enzyme cytochrome P450 3A4 is prohibited throughout the study.
• •9. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel.
• •10. 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.
• +5 more criteria