Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Condition: Advanced Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Placebo
Intervention description: Patches will contain 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.; Placebo patches match the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Rotigotine; Chronic Pain; Nonmotor symptoms

Summary:

      This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain
      associated with Parkinson's Disease among patients with advanced stages of the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed
             by a Likert Pain Scale

          -  Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21
             days prior to start

          -  Hoehn and Yahr stage score of II to IV

          -  Mini-Mental State Examination (MMSE) score ≥ 25

          -  If an antidepressant drug is taken, the dose must be stable for at least 21 days

        Exclusion Criteria:

          -  Therapy with a Dopamine Agonist within 21 days prior to start

          -  Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy

          -  Therapy with Dopamine-modulating substances 21 days prior to start

          -  Therapy with analgesics for the treatment for pain, unless the dose has been stable

          -  Chronic alcohol or drug abuse

          -  Medical or psychiatric condition that, in the opinion of the investigator, could
             jeopardize or would compromise the patient's ability to participate in this study

          -  Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or
             comparative drugs

          -  Atypical Parkinson's Disease Syndrome due to drugs

          -  History of deep brain stimulation

          -  Significant skin disease that would make transdermal drug use inappropriate

          -  Electroconvulsive therapy within 12 weeks prior to start

          -  Evidence of an Impulse Control Disorder

          -  Previous diagnosis of severe Restless Legs Syndrome

          -  Chronic Migraine

          -  Severe Depression

          -  Symptomatic Orthostatic Hypotension