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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01140841
First received: June 8, 2010
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole in adult patients with Parkinson's disease who are receiving levodopa.


Condition Intervention Phase
Parkinson's Disease
Drug: Fipamezole ODT
Drug: Placebo
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess cardiovascular safety of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [ Time Frame: Days -28 to 56 ] [ Designated as safety issue: Yes ]
  • To evaluate pharmacokinetics (PK) of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [ Time Frame: Days -28 to 56 ] [ Designated as safety issue: Yes ]
  • To assess incidence and severity of Adverse Events [ Time Frame: Days -28 to 63 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fipamezole ODT Drug: Fipamezole ODT
Subjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks.
Placebo Drug: Placebo
1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.

Detailed Description:

Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in the early phases of the disease, their benefits decrease with disease progression, and problems such as dyskinesia and on-off phenomenon begin to manifest. In this study, fipamezole, a new antagonist of an adrenergic receptor, is being investigated to better understand the safety and side-effect profile in patients with Parkinson's Disease.

The sampling method used was simple random sampling.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Parkinson's Disease on stable regimen of levodopa

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140841

Locations
United States, California
CNS Network, Inc.
Torrance, California, United States, 90502
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, New Jersey
Clinical Research Integrity Worldwide LLC
Willingboro, New Jersey, United States, 08046
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Karen Briegs Biovail Technologies, Ltd.
  More Information

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01140841     History of Changes
Other Study ID Numbers: BVF-025-101
Study First Received: June 8, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014