A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease

February 25, 2014 updated by: UCB BIOSCIENCES GmbH

An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4

The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • 101
      • Busan, Korea, Republic of
        • 102
      • Daegu, Korea, Republic of
        • 109
      • Daegu, Korea, Republic of
        • 108
      • Gyeonggi-Do, Korea, Republic of
        • 105
      • Seoul, Korea, Republic of
        • 103
      • Seoul, Korea, Republic of
        • 107
      • Seoul, Korea, Republic of
        • 104
      • Seoul, Korea, Republic of
        • 106
  • Malaysia
      • Sarawak, Malaysia
        • 202
  • Singapore
      • Singapore, Singapore
        • 401
      • Singapore, Singapore
        • 403
  • Taiwan
      • Linkou, Taiwan
        • 301
      • Taichung, Taiwan
        • 304
      • Taipei, Taiwan
        • 305
  • United States
    • Alabama
      • Anniston, Alabama, United States
        • 505
    • Florida
      • Atlantis, Florida, United States
        • 506
      • Miami Springs, Florida, United States
        • 508
    • Georgia
      • Atlanta, Georgia, United States
        • 502
    • Ohio
      • Dayton, Ohio, United States
        • 501
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 509

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes and is without any other known or suspected cause of Parkinsonism
  • Subject has motor fluctuations
  • Subject is not satisfactorily controlled following the investigator´s assessment on a total daily dose of Pramipexole or Ropinirole
  • Subject has sleep disturbance or early morning motor impairment
  • Subject has experienced nocturia for at least 3 nights within 7 days prior to the Baseline Visit
  • Subject is taking L-dopa in combination with Benserazide or Carbidopa and has been on a stable dose of L-dopa for at least 28 days prior to the Baseline Visit

Exclusion Criteria:

  • Subject has had therapy with Tolcapone or Budipine
  • Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
  • Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline (Visit 2)
  • Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations, or recent unsolved contact dermatitis
  • Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment
  • Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least 1 barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal
  • Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotigotine

First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.

  • Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
  • Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Drug: Rotigotine
Rotigotine up to 16 mg / 24 hours, 4 weeks.
Other Names:
  • Neupro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
Time Frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:

  • 0 = Side effects not assessable
  • 1 = No side effects
  • 2 = Side effects do not significantly interfere with subject's functioning
  • 3 = Side effects significantly interfere with the subject's functioning
  • 4 = Side effects outweigh therapeutic efficacy.
Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
Time Frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:

  • 1 = Very much improved
  • 2 = Much improved
  • 3 = Minimally improved
  • 4 = No change
  • 5 = Minimally worse
  • 6 = Much worse
  • 7 = Very much worse.
Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB BIOSCIENCES GmbH

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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