Mucuna pruriens in Parkinson disease: an international clinical trial

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201611001882367
• Date of registration: 21/11/2016
• Prospective Registration: Yes
• Primary sponsor: Fondazione Grigioni per il Morbo di Parkinson
• Public title: Mucuna pruriens in Parkinson disease: an international clinical trial
• Scientific title: Mucuna pruriens in Parkinson disease: an international multicentre, non-inferiority, randomised, controlled clinical trial
• Date of first enrolment: 05/06/2017
• Target sample size: 70
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1882
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,computer generated randomization list (permuted-block randomization with varying block sizes),Concealment will be attained by using sealed envelopes.
• Phase: Not Applicable

Countries of recruitment

Ghana, Zambia

Contacts

• Name: Roberto Cilia
• Affiliation: Medical Doctor, Consultant Neurologist

• Name: Roberto Cilia
• Affiliation: Medical Doctor, Consultant Neurologist

Key inclusion & exclusion 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: (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.

Age minimum: 19 Year(s)
Age maximum: 44 Year(s)
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinsons Disease

Parkinsons Disease

Intervention(s)

Levodopa/Benserazide 200+50mg

MP group

Primary Outcome(s)

Summary index of the 39-item Parkinson¿s Disease Questionnaire (PDQ-39) quality-of-life scale (Jankinson et al., 1997)

Secondary Outcome(s)

(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

(e) any adverse events defined as the frequency, severity, nature, and duration of any adverse event throughout the course of the study

(b) number of patients withdrawn from the study or lost to follow up

(d) levodopa-induced motor response fluctuations throughout the course of the study measured with items 36 to 39 of the UPDRS part IV

(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)

Source(s) of Monetary Support

Fondazione Grigioni per il Morbo di Parkinson

Ethics review

Status: Not approved
Approval date:
Contact:

COMMITTEE ON HUMAN RESEARCH, PUBLICATIONS AND ETHICS, KATH

Status: Not approved
Approval date:
Contact:

KBTH Research & Development

Status: Not approved
Approval date:
Contact:

UNZA Biomedical Research Ethics Committee (UNZABREC)