A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low
 doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)
 who have insufficient response to L-dopa and low doses dopamine receptor agonists.
Inclusion Criteria:

 -  Subject is male or female, aged ≥ 30 and < 80 years at informed consent

 -  Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined
 by the cardinal sign, bradykinesia, and the presence of at least 1 of the following:
 resting tremor, rigidity, impairment of postural reflexes, and without any known or
 suspected cause of Parkinsonism

 -  Subject has motor fluctuations such as wearing, dyskinesia

 -  Subject has experienced nocturias for at least 3 nights within 7 days prior to
 Baseline

 -  Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in
 combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for
 at least 28 days prior to Baseline (Visit 2)

 -  Subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole
 ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least
 28 days prior to Baseline (Visit 2)

 Exclusion Criteria:

 -  Subject is receiving 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 (except specific atypical neuroleptics: olanzapine,
 ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A)
 inhibitors, methylphenidate, or amphetamine

 -  Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within
 the 6 months prior to Baseline (Visit 2)

 -  Subject has a known hypersensitivity to any components of the study medication, such
 as a history of significant skin hypersensitivity to adhesives, known hypersensitivity
 to other transdermal medications, or has unresolved contact dermatitis

 -  Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not
 surgically sterile, or, (ii) not using adequate birth control methods [including at
 least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2
 years post menopausal)

 -  Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs
 syndrome, or periodic limb movement disorder