| Criteria: |
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Inclusion Criteria:
1. Subject is a man or woman between 30 and 75 years of age, inclusive, with intact oral
mucosa at Screening (Visit 1) and Randomization (Visit 2).
2. Subject has a diagnosis of idiopathic Parkinson's disease defined according to the UK
Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria.
3. Subject has been receiving a stable regimen of at least three daily administrations
of levodopa (with a peripheral dopa decarboxylase inhibitor), with no dose changes
for at least 4 weeks prior to Randomization (Visit 2).
4. Subject is rated at stage 2 to 4 on the Hoehn and Yahr scale.
5. If currently taking other medications (other than levodopa), subject must be on a
stable regimen, defined as no dose changes for at least 1 month prior to
Randomization (Visit 2).
6. Subject demonstrates the ability to comprehend the study procedures and provide
informed consent.
7. Female subjects must be either postmenopausal for at least 1 year or surgically
sterilized at least 3 months prior to Randomization (Visit 2). Male subjects must
either be sterile or willing to use 2 approved methods of contraception when engaged
in sexual intercourse with a female partner from Randomization (Visit 2) until 30
days after the last dose of study drug.
Exclusion Criteria:
1. Subject participated in an investigational medication study within the 3 months prior
to Randomization (Visit 2).
2. Subject has immediate family members who are site Investigators or sponsor employees.
3. Subject has a history or presence of clinically significant cardiovascular,
pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic,
dermatologic, neurologic, or oncologic or any other condition that, in the opinion of
the Investigator, would jeopardize the safety of the subject or the validity of the
study results.
4. Subject has impaired renal function (defined as a creatinine level of ≥ 1.5 times the
upper limit of normal) at Screening (Visit 1).
5. Subject has impaired hepatic function (defined as SGOT/AST or SGPT/ALT levels ≥ 1.5
times the upper limit of normal) at Screening (Visit 1).
6. Subject has second- or third-degree atrioventricular block or sick sinus syndrome,
atrial fibrillation, atrial flutter, severe or unstable angina, congestive heart
failure, or myocardial infarction within 3 months of the screening visit or a
significant ECG abnormality, including a QRS > 110 msec, a PR interval > 230 msec, a
QTc ≥ 450 msec for male subjects, or a QTc ≥ 470 msec for female subjects.
7. Subject is at immediate risk of requiring hospitalization.
8. Subject has, in the opinion of the Investigator, a clinically important abnormality
on his/her physical examination, electrocardiography, vital sign measurements, or
laboratory assessment.
9. Subject is being treated with a disallowed medication that cannot be discontinued
prior to Randomization (Visit 2) (see Table 5).
10. Subject has a current diagnosis of substance abuse or history of alcohol or drug
abuse in the past 2 years prior to Screening (Visit 1).
11. Subject has positive findings on urine drug screen at Screening (Visit 1).
12. Subject has an allergy to fipamezole or the excipients. |