Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; Rotigotine
Intervention description: Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.; Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro®; Non-motor symptoms

Summary:

      The primary objective of this study was to demonstrate that Rotigotine improves non-motor
      symptoms compared to Placebo in subjects with Parkinson's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, ≥18 years of age

          -  Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal
             signs being present: bradykinesia, resting tremor, rigidity or postural instability,
             and without any other known or suspected cause of Parkinsonism

          -  Subject has a Hoehn and Yahr stage score ≤4

          -  Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40

          -  If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA
             (in combination with benserazide or carbidopa) for at least 28 days prior to the
             Baseline Visit

          -  If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or
             amantadine, he/she must have been on a stable dose for at least 28 days prior to the
             Baseline Visit and must be maintained on that dose for the duration of the study

        Exclusion Criteria:

          -  Subject discontinued from previous therapy with a dopamine agonist after an adequate
             length of treatment, at an adequate dose, due to lack of efficacy as assessed by the
             investigator

          -  Subject is receiving therapy with 1 of the following drugs, either concurrently or
             within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide,
             reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine,
             ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A)
             inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)

          -  Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics,
             selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying
             medication) unless dose has been stable daily for at least 28 days prior to the
             Baseline Visit and is likely to remain stable for the duration of the study

          -  Subject has evidence of an impulse control disorder according to the modified
             Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by
             a positive structured clinical interview