Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Perampanel
Intervention description: 1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Healthy volunteers: No

Summary:

      A 48-month open label multi-centered extension study to evaluate the long-term safety,
      tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off"
      motor fluctuations and "on" period Dyskinesias.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients enrolled in Study E2007-E044-204 and who either completed 12 weeks of study
             drug treatment or who withdrew from the study due to lack of efficacy.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Women of child bearing potential unless infertile (including surgically sterile) or
             practicing effective contraception (e.g. abstinence, IUD-intrauterine device, or
             barrier method plus hormonal method). 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.

          -  Fertile men not willing to use reliable contraception and fertile men with partners
             not willing to use reliable contraception. These patients and their partners must also
             be willing to remain using reliable contraception for the duration of the study.

          -  Patients with a past or present history of drug or alcohol abuse.

          -  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 have been kept stable for at least 8 weeks prior to baseline
             visit.

          -  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.

          -  Patients with significantly elevated liver enzymes (abnormal bilirubin or serum
             transaminase levels of more than 1.5 times the upper normal limit).

          -  Patients with current or prior treatment (within 4 weeks prior to the Baseline visit)
             with medication known to induce the enzyme cytochrome P450 3A4 including but not
             limited to; carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin;
             primidone; rifabutin; rifampicin; and St John's Wort.

          -  Current or prior treatment (within 4 weeks prior to baseline visit) with methyldopa,
             budipine, reserpine or intermittent use of liquid forms of levodopa or as needed (prn)
             apo-morphine.

          -  Patients with previous stereotactic surgery (e.g. pallidotomy) for Parkinson's disease
             or who are likely to undergo surgery for Parkinson's disease while participating in
             this study.

          -  Patients receiving deep brain stimulation (DBS) or who are likely to undergo DBS for
             Parkinson's disease while participating in the extension study.

          -  Patients with clinically significant cognitive impairment (mini-mental state
             examination (MMSE) <24 and /or fulfilling diagnostic and statistical manual of mental
             disorders (DSM IV) criteria for dementia due to Parkinson's disease).

          -  Patients with conditions affecting the peripheral or central sensory system.