Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Perampanel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This is a multicentre, open-label extension study to evaluate the long-term safety,
      tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated
      PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or
      E2007-G000-309 will be candidates for entering this extension trial, provided that they meet
      the inclusion/exclusion criteria and have completed the core study, up to and including the
      final efficacy visit.
    

Eligibility criteria:

        INCLUSION CRITERIA:

        Male or female subjects with idiopathic PD who have fulfilled the entry criteria to studies
        E2007-G000-309 or E2007-E044-213.

        Subjects must have completed the core efficacy study up to and including the final efficacy
        and follow up visits as applicable.

        Subjects with mild or moderate AEs thought to be related to Perampanel (E2007) can be
        entered into the study if the investigator considers it safe.

        EXCLUSION CRITERIA:

          1. Show evidence of clinically significant disease (i.e., severe cardiovascular or
             pulmonary disease, bronchial asthma, endocrine disease, history of peptic ulcer
             disease, history of myocardial infarction with residual atrial nodal or ventricular
             arrhythmias) that, in the opinion of the investigator, could affect either the
             patient's safety or the conduct of the study.

          2. Pregnant or lactating women.

          3. Women of childbearing potential (WOCBP) unless infertile (including surgically
             sterile) or practicing effective contraception (e.g., intrauterine device [IUD] or
             barrier method plus hormonal method). These subjects must have a negative urine
             pregnancy test at Visit 1 or 2 as indicated by entry into the study. These subjects
             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.

          4. Subjects with a past (within the past 5 years) or present history of drug or alcohol
             abuse as per Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition
             (DSM IV) criteria.

          5. Antipsychotics are permitted as necessary. Subjects may be taking anti-depressant
             medication, however the dose must be stable for 4 weeks prior to their first study
             visit (the visit at which the inclusion and exclusion criteria are done with the
             patient).

          6. Subjects with a past (within one year) or present history of major depression,
             suicidal ideation, or suicide attempts.

          7. Subjects with unstable abnormalities of the hepatic, renal, cardiovascular,
             respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that
             might complicate assessment of the tolerability of the study medication.

          8. Subjects with significantly elevated liver enzymes (abnormal bilirubin or serum
             transaminase levels of more than 1.5 times the upper limit of the normal range).

          9. Subjects with current or prior treatment (within 4 weeks prior to the Screening Visit)
             with medication known to induce the enzyme CYP3A4.

         10. Clinically significant ECG abnormality, and/or prolonged QTc (defined as QTc ≥ 450
             msec).

         11. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone,
             methyldopa, budipine, or reserpine.

         12. Subjects with previous stereotactic surgery (e.g., pallidotomy) for PD or with planned
             stereotactic surgery during the study period

         13. Subjects receiving or with planned (next 12 months) deep brain stimulation.

         14. Subjects with conditions affecting the peripheral or central sensory system unless
             related to PD (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
             medication.

         15. Subjects have received an investigational product (other than E2007 or entacapone 200
             mg) within 4 weeks prior to Screening

         16. Any condition that could, in the opinion of the investigator, place the subject at
             increased risk or is likely to prevent completion of the study.

         17. Subjects with any condition that would make the subject, in the opinion of the
             investigator, unsuitable for the study.

         18. Patients on pergolide or cabergoline.