A Study of E2007 In Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: E2007
Intervention description: E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will
      receive active study drug. The study will involve outpatient visits only. Patients who
      completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria
      will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0
      [Visit 2] through Week 12 [Visit 7]) followed by the Maintenance Phase (from Week 12 [Visit
      7] to end of study).
    

Eligibility criteria:

        INCLUSION CRITERIA

        1. Male or female patients with idiopathic Parkinson's disease who have fulfilled the entry
        criteria for E2007-A001-214 and have completed that study up to and including the end of
        treatment (Day 70) visit and the Follow-up Visit at Day 91.

        EXCLUSION CRITERIA

          1. Pregnant or lactating women.

          2. Women of child bearing potential unless infertile (including surgically sterile) or
             practicing effective contraception (e.g., intrauterine device or barrier method plus
             hormonal method). These patients must have a negative serum beta human chorionic
             gonadotropin (B-HCG) test at the initial visit (Visit 1) and urine pregnancy tests
             throughout the study. 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
             nonchildbearing potential as determined by the investigator.

          3. Patients who withdrew from Study 214 prior to the final efficacy visit for any reason,
             including lack of efficacy.

          4. Patients with serious adverse events in Study 214 that are either ongoing or that are
             possibly or probably related to the study drug.

          5. Patients with ongoing adverse events from Study 214 thought to be related to E2007.

          6. Patients with a past (within the past 5 years) or present history of drug or alcohol
             abuse as per the criteria in the Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM IV).

          7. Patients with a past (within 1 year) or present history of psychotic symptoms
             requiring antipsychotic treatment.

          8. Patients with a past (within 1 year) or present history of suicidal ideation or
             suicide attempts.

          9. Patients with active hepatic disease, significantly reduced hepatic function or
             significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels
             of more than 1.5 times the upper limit of the normal range).

         10. Patients with clinically significant ECG abnormality, including prolonged QTc (defined
             as QTc >= 450 msec using Fridericia's correction).

         11. Patients with clinically significant cardiovascular, metabolic, respiratory, renal,
             endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or
             viral infections within the previous 30 days.

         12. Patients who are currently taking medications known to induce the enzyme cytochrome
             P450 3A4.

         13. Patients with current or prior treatment (within 4 weeks before entry visit) with
             tolcapone, methyldopa, budipine, reserpine, seroquel, or intermittent use of either
             liquid forms of levodopa or subcutaneous apomorphine.

         14. Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's
             disease or with planned stereotactic surgery during the study period.

         15. Patients receiving or with planned (next 6 months) deep brain stimulation.

         16. 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.

         17. Patients with any condition that would make the patient, in the opinion of the
             investigator, unsuitable for the study.

         18. Patients who have received an investigational product (other than E2007) within 4
             weeks before screening.

         19. Patients with clinically significant cognitive impairment (mini-mental state
             examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's
             disease).

         20. Patients with any condition that could, in the opinion of the investigator, place the
             patient at increased risk or is likely to prevent completion of the study.