A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01140841
• Date of registration: 08/06/2010
• Prospective Registration: No
• Primary sponsor: Valeant Pharmaceuticals International, Inc.
• Public title: A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa Fipamezole
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
• Date of first enrolment: June 2010
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01140841
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Karen Briegs
• Affiliation: Biovail Technologies, Ltd.

Key inclusion & exclusion criteria

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.

8. Subject has an upper arm circumference of not less than 24 cm and not more than 42 cm
for both arms.

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 has a history of risk factors for Torsades de Pointes, including unexplained
syncope, known long QT syndrome, or a clinically significant abnormal laboratory
assessment such as hypokalemia, hypercalcemia, or hypomagnesemia. Subjects with a
family history of long QT syndrome or Brugada syndrome will also be excluded.

8. Subject is at immediate risk of requiring hospitalization.

9. Subject has significant tremor or dyskinesia which, in the opinion of the
Investigator, might interfere with reliable assessment of continuous Holter ECG and
ABPM.

10. Subject has, in the opinion of the Investigator, a clinically important abnormality
on his/her physical examination, electrocardiography, vital sign measurements, or
laboratory assessment.

11. Subject is being treated with a disallowed medication that cannot be discontinued
prior to Randomization (Visit 2) (See Table 6).

12. 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).

13. Subject has positive findings on urine drug screen at Screening (Visit 1).

14. Subject has an allergy to fipamezole or its excipients.



Age minimum: 30 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Fipamezole ODT

Drug: Placebo

Primary Outcome(s)

To determine the Maximum Tolerated Dose (MTD) of Fipamezole orally disintegrating tablets (ODT) in adult patients with Parkinson's disease. [Time Frame: Days -28 to 56]

Secondary Outcome(s)

To assess cardiovascular safety of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [Time Frame: Days -28 to 56]

To evaluate pharmacokinetics (PK) of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [Time Frame: Days -28 to 56]

To assess incidence and severity of Adverse Events [Time Frame: Days -28 to 63]

Secondary ID(s)

BVF-025-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors