Mucuna Pruriens Therapy in Parkinson's Disease

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In low-income areas worldwide, most patients with Parkinson's disease (PD) cannot afford long-term Levodopa therapy. A potential therapeutic option for them is the use of a legume called Mucuna Pruriens var. Utilis (MP), which has seeds with a high levodopa content (5-6%) and grows in all tropical areas of the world. MP powder is very cheap (total annual cost for a PD patient: 10-15 US $). The aim of this study is to assess efficacy and tolerability of acute and chronic use of MP compared to standard Levodopa therapy.

The primary objective of this study is to investigate efficacy of acute levodopa challenge using MP in comparison to levodopa with a Dopa Decarboxylase Inhibitor (LD+DDCI) and without (LD-DDCI) and placebo.

The secondary objectives are to investigate safety of acute intake of MP as well as efficacy and safety of chronic intake of MP over a 8-week period in comparison to usual LD+DDCI home therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASST Gaetano Pini-CTO
• Collaborators: Fondazione Grigioni per il Morbo di Parkinson; Grisons Foundation for Parkinson's Disease
• Treatments: Benserazide; Benserazide, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria:

• Clinical diagnosis of idiopathic Parkinson's disease according to the United Kingdom Brain Bank criteria, defined by the presence of at least two of the cardinal signs of the disease (resting tremor, bradykinesia, rigidity) without any other known cause of parkinsonism.

• Sustained response to levodopa and presence of motor fluctuations for at least 1 h every day during waking hours, defined as predictable wearing-off, unpredictable ON-OFF fluctuations and sudden OFF periods.

• Patients had to receive optimum LD+DDCI, be stable for at least 30 days before baseline assessment.

• Availability to written informed consent

Exclusion Criteria:

• Cognitive impairment according to Mini-Mental State Examination < 26/30

• Clinically significant psychiatric illness, including psychosis, major depression and addiction disorders (including compulsive levodopa intake).

• Hoehn and Yahr stage of 5/5 in the medication-OFF state

• Severe, unstable medical conditions (i.e. unstable diabetes mellitus, moderate to severe renal or hepatic impairment, neoplasms)

• Risk of pregnancy