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
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro

Summary:

      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.
    

Eligibility criteria:

        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