drugset / Trial / NCT02680977

Mucuna Pruriens Therapy in Parkinson's Disease

NCT02680977

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2016-02
Primary completion
2016-05
Completion
2016-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levodopa Small molecule 3.5 mg/kg
Comparator Levodopa Small molecule 17.5 mg/kg
Comparator benserazide Small molecule

Indications