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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

Primary Purpose

Advanced Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Idiopathic Parkinson's Disease focused on measuring Rotigotine, Neupro, Switch, Dopamine agonists

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 505
  • 506
  • 508
  • 502
  • 501
  • 509
  • 101
  • 102
  • 108
  • 109
  • 105
  • 103
  • 104
  • 106
  • 107
  • 202
  • 401
  • 403
  • 301
  • 304
  • 305

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotigotine

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the 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.

Secondary Outcome Measures

Patients Global Impressions of Change (PGIC) at the End of the 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.

Full Information

First Posted
October 18, 2012
Last Updated
February 25, 2014
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01711866
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Idiopathic Parkinson's Disease
Keywords
Rotigotine, Neupro, Switch, Dopamine agonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
Rotigotine up to 16 mg / 24 hours, 4 weeks.
Primary Outcome Measure Information:
Title
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
Description
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.
Time Frame
Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Secondary Outcome Measure Information:
Title
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
Description
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.
Time Frame
Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
505
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
506
City
Atlantis
State/Province
Florida
Country
United States
Facility Name
508
City
Miami Springs
State/Province
Florida
Country
United States
Facility Name
502
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
501
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
509
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
101
City
Busan
Country
Korea, Republic of
Facility Name
102
City
Busan
Country
Korea, Republic of
Facility Name
108
City
Daegu
Country
Korea, Republic of
Facility Name
109
City
Daegu
Country
Korea, Republic of
Facility Name
105
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
103
City
Seoul
Country
Korea, Republic of
Facility Name
104
City
Seoul
Country
Korea, Republic of
Facility Name
106
City
Seoul
Country
Korea, Republic of
Facility Name
107
City
Seoul
Country
Korea, Republic of
Facility Name
202
City
Sarawak
Country
Malaysia
Facility Name
401
City
Singapore
Country
Singapore
Facility Name
403
City
Singapore
Country
Singapore
Facility Name
301
City
Linkou
Country
Taiwan
Facility Name
304
City
Taichung
Country
Taiwan
Facility Name
305
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25846031
Citation
Chung SJ, Kim JM, Kim JW, Jeon BS, Singh P, Thierfelder S, Ikeda J, Bauer L; Asia Pacific Rotigotine Switching Study Group. Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study. Expert Opin Pharmacother. 2015 May;16(7):961-70. doi: 10.1517/14656566.2015.1030336. Epub 2015 Apr 6.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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