World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03648671
Date of registration: 26/06/2018
Prospective Registration: No
Primary sponsor: Universita di Verona
Public title: Pain in Parkinson's Disease With Motor Fluctuations. PAINinPD
Scientific title: Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.
Date of first enrolment: March 28, 2018
Target sample size: 48
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT03648671
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Italy
Contacts
Name:     Michele Tinazzi, MD, PhD
Address: 
Telephone: 0458027472
Email: michele.tinazzi@univr.it
Affiliation: 
Name:     Michele Tinazzi, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Azienda Ospedaliera Universitaria Integrata Verona
Name:     Michele Tinazzi, MD, PhD
Address: 
Telephone: 0458027472
Email: michele.tinazzi@univr.it
Affiliation: 
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
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: rasagilina mesilato (12 weeks)
Drug: safinamide metansolfonato (12 weeks)
Primary Outcome(s)
Amplitude (microvolt) of N2/P2 complex. [Time Frame: Change from baseline at 12 weeks]
Latency (ms) of N1/P1 complex. [Time Frame: Change from baseline at 12 weeks]
Latency (ms) of N2/P2 complex. [Time Frame: Change from baseline at 12 weeks]
Amplitude (microvolt) of N1/P1 complex. [Time Frame: Change from baseline at 12 weeks]
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]
Secondary ID(s)
1470CESC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Azienda Ospedaliera Universitaria Integrata Verona
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history