Key inclusion & exclusion criteria
|
Inclusion Criteria:
- PD patients with or without pain willing to participate in this study and able to sign
the written informed consent
- To be included in the PD with pain group, the patient's intensity of pain must be
moderate to severe over the last month, as reported by a numerical rating scores
(NRS=4) despite the optimal dopaminergic treatment
- No modification of dopaminergic drugs and analgesic therapy with FANS during the 28
days before starting the enrollment in this study.
- Diagnosis of idiopathic PD of =3 years duration
- Hoehn and Yahr stage I-III during OFF time
- Motor fluctuations (>1.5 hours' OFF time/day)
- Patients who would have been treated with add-on therapy irrespective to the present
protocol
Exclusion Criteria:
- Patients under (or with previous assumptions) monoamine oxidase inhibitor therapy.
- Late-stage PD experiencing severe, disabling peak-dose or biphasic dyskinesia, or
unpredictable or widely swinging symptom fluctuations
- "de novo" patients, patients in early stage or non-fluctuating patients
- Evidence of dementia (MMSE <24)
- Sign and symptoms suggestive of atypical parkinsonism
- Major psychiatric illnesses
- Severe and progressive medical illnesses
- Concomitant diseases potentially causing acute or chronic pain (i.e., rheumatologic
conditions, severe polyneuropathy, and spine injuries)
- Treatments with tri-tetracyclic antidepressants, serotonin-norepinephrine reuptake
inhibitors (SNRIs), opioids, neuroleptics, barbiturates and phenothiazines, pregabalin
and gabapentin
- Any type of retinopathy
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
Secondary Outcome(s)
|
Age at PD onset
[Time Frame: One timepoint]
|
Total daily off time
[Time Frame: Change from baseline at 12 weeks]
|
Gender
[Time Frame: One timepoint]
|
Off time following the first morning L-dopa dose
[Time Frame: Change from baseline at 12 weeks]
|
Pain symptoms at PD onset
[Time Frame: One timepoint]
|
Schooling
[Time Frame: One timepoint]
|
Laterality of PD symptom onset
[Time Frame: One timepoint]
|
Modified H&Y
[Time Frame: One timepoint]
|
Age
[Time Frame: One timepoint]
|
Clinical global impression of change
[Time Frame: Change from baseline at 12 weeks]
|
Comorbilities
[Time Frame: One timepoint]
|
Dominant phenotype
[Time Frame: One timepoint]
|
Job
[Time Frame: One timepoint]
|
Pharmacologic therapy for PD
[Time Frame: One timepoint]
|
Italian version of the brief pain inventory short form
[Time Frame: Change from baseline at 12 weeks]
|
Mini-Mental State Examination
[Time Frame: One timepoint]
|
Body localization
[Time Frame: Change from baseline at 12 weeks]
|
Disease duration
[Time Frame: One timepoint]
|
Numeric Rating Scale (NRS)
[Time Frame: Change from baseline at 12 weeks]
|
Unified Parkinson's Disease Rating Scale
[Time Frame: Change from baseline at 12 weeks]
|
The 39-Item Parkinson's Disease Questionnaire (PDQ-39)
[Time Frame: Change from baseline at 12 weeks]
|
Weight
[Time Frame: One timepoint]
|
King's Pain Scale for Parkinson's Disease
[Time Frame: Change from baseline at 12 weeks]
|
Most Affected Side
[Time Frame: One timepoint]
|
Montreal Cognitive Assessment (MoCA)
[Time Frame: One timepoint]
|