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
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | September 2012 |
End Date: | March 2013 |
Contact: | UCB Clinical Trial Call Center |
Phone: | +1 877 822 9493 |
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.
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
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