CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
LD+DDCI +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02680977
NCT02680977Phase 2Completed

Mucuna Pruriens Therapy in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomized, Crossover Study.

ASST Gaetano Pini-CTO·interventional·Posted Feb 12, 2016·Updated Oct 5, 2016

In Brief

A Phase 2 clinical trial evaluating MP-Equivalent, MP-Low, and 4 other interventions for Parkinson's Disease. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBolivia

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 12, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMay 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.4 years ago

Interventions

MP-Equivalentother

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.

MP-Lowother

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

MP+DDCIother

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.

LD+DDCIdrug

Levodopa plus Benserazide

LD-DDCIdrug

Levodopa without any DDCI

Placeboother

Groundnuts powder