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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rotigotine	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.

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit	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.

Secondary Outcome Measures

Name	Time	Method
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit	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.

Locations (21): 106
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Seoul, Korea, Republic of
102
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Busan, Korea, Republic of
505
🇺🇸
Anniston, Alabama, United States
508
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Miami Springs, Florida, United States
104
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Seoul, Korea, Republic of
509
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Oklahoma City, Oklahoma, United States
101
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Busan, Korea, Republic of
506
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Atlantis, Florida, United States
103
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Seoul, Korea, Republic of
501
🇺🇸
Dayton, Ohio, United States
108
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Daegu, Korea, Republic of
502
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Atlanta, Georgia, United States
109
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Daegu, Korea, Republic of
107
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Seoul, Korea, Republic of
105
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Gyeonggi-Do, Korea, Republic of
202
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Sarawak, Malaysia
403
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Singapore, Singapore
301
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Linkou, Taiwan
401
🇸🇬
Singapore, Singapore
305
🇨🇳
Taipei, Taiwan
304
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Taichung, Taiwan