Nervous System Diseases Parkinsons Disease
Conditions
Interventions
MP group
Levodopa/Benserazide 200+50mg
Sponsors
Fondazione Grigioni per il Morbo di Parkinson
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (a) diagnosis of idiopathic PD according to UK Brain Bank criteria (Hughes et al., 1992); (b) newly diagnosed PD within the past 2 years; (c) never treated with levodopa or treated for ¿6 months during the disease course but levodopa discontinued since at least 3 months; (d) age ¿30 years.
Exclusion criteria
Exclusion criteria: (i) signs of cognitive impairment (according to DSM-IV-TR criteria or MMSE<26) limiting the availability for a written informed consent; (ii) clinically significant psychiatric illness (e.g. severe depression or psychosis); (iii) Hoehn and Yahr stage 5/5; (iv) severe, unstable medical conditions (e.g. neoplasms; unstable diabetes mellitus; heart, renal or liver failure); (v) pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summary index of the 39-item Parkinson¿s Disease Questionnaire (PDQ-39) quality-of-life scale (Jankinson et al., 1997) | — |
Secondary
| Measure | Time frame |
|---|---|
| (b) number of patients withdrawn from the study or lost to follow up;(a) the patient-rated functional status on the mobility subscale of the PDQ-39 and other domains such as compliance;(c) dyskinesias, measured with items 32 to 35 of the UPDRS part IV;(d) levodopa-induced motor response fluctuations throughout the course of the study measured with items 36 to 39 of the UPDRS part IV;(e) any adverse events defined as the frequency, severity, nature, and duration of any adverse event throughout the course of the study;(f) working status and absence from paid and (g) resource utilisation outside of the participating hospitals work, measured with a standardised questionnaires (Verschuur et al., 2015) | — |
Countries
Ghana
Contacts
Public ContactRoberto;Roberto Cilia;Cilia
Consultant Neurologist;Consultant Neurologist
Outcome results
None listed