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

Completed · Phase 4

Conditions studied: Advanced Idiopathic Parkinson's Disease

In brief

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.

Key facts

Study ID: NCT01711866
Run by: UCB BIOSCIENCES GmbH
People needed: 87
Starts: 2012-09-01
Expected to finish: 2013-03-01
Last updated by the study team: 2014-04-07

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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