Mucuna Pruriens Therapy in Parkinson's Disease

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.

Conditions

• Parkinson's Disease

Interventions

OTHER

MP-Equivalent

Mucuna pruriens powder at equivalent dosage than LD+DDCI. The dose of MP is calculated to obtain a 5-fold Levodopa dose than LD+DDCI.

OTHER

MP-Low

Mucuna pruriens powder at low dosage. The dose of MP is calculated to obtain a 3.5-fold Levodopa content than LD+DDCI

OTHER

MP+DDCI

Mucuna pruriens powder plus Benserazide. The dosage of MP is calculated to obtain the same Levodopa content than LD+DDCI. Benserazide is given as 1:4 ratio with Levodopa.

DRUG

LD+DDCI

Levodopa plus Benserazide

DRUG

LD-DDCI

Levodopa without any DDCI

OTHER

Placebo

Groundnuts powder

Sponsors & Collaborators

• Grisons Foundation for Parkinson's Disease

  collaborator OTHER

• ASST Gaetano Pini-CTO

  lead OTHER

Principal Investigators

• Roberto Cilia, MD · ASST Gaetano Pini-CTO

• Gianni Pezzoli, MD · ASST Gaetano Pini-CTO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2016-05-31

Completion

2016-09-30

Countries

• Bolivia

Study Locations