Mucuna pruriens in Parkinson disease: an international clinical trial
Not Applicable
- Conditions
- Parkinsons Disease
- Registration Number
- PACTR201611001882367
- Lead Sponsor
- Fondazione Grigioni per il Morbo di Parkinson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 70
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
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Summary index of the 39-item Parkinson¿s Disease Questionnaire (PDQ-39) quality-of-life scale (Jankinson et al., 1997)
- Secondary Outcome Measures
Name Time Method (b) number of patients withdrawn from the study or lost to follow up;(a) the patient-rated functional status on the mobility subscale of the PDQ-39 and other domains such as compliance;(c)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)