Mucuna Pruriens Therapy in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02680977|
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : October 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Other: MP-Equivalent Other: MP-Low Other: MP+DDCI Drug: LD+DDCI Drug: LD-DDCI Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mucuna Pruriens Therapy in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomized, Crossover Study.|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||September 2016|
Experimental: MP-Equivalent; MP-Low; MP+DDCI
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 (for example 100mg of Madopar corresponds to 500mg of Levodopa in MP).
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 (for example 100mg of Madopar corresponds to 350mg of Levodopa in MP) MP+DDCI: Mucuna pruriens powder plus Benserazide. The dosage of MP is calculated to obtain the same Levodopa content than LD+DDCI (for example 100mg of Madopar corresponds to 100mg of Levodopa in MP plus 25mg of Benserazide)
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 Name: Mucuna pruriens at equivalent dose than LD-DDCI
Mucuna pruriens powder at low dosage. The dose of MP is calculated to obtain a 3.5-fold Levodopa content than LD+DDCI
Other Name: Mucuna pruriens at low dosage
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.
Other Name: Mucuna pruriens plus Benserazide
Active Comparator: LD+DDCI; LD-DDCI
LD+DDCI: Levodopa plus Benserazide (dispersible formulation). The dose is calculated as 3.5mg per kg of body weight.
LD-DDCI: Levodopa without any dopa decarboxylase inhibitor (galenic formulation). The dose is 5-fold than LD+DDCI.
Levodopa plus Benserazide
Other Name: Madopar
Levodopa without any DDCI
Other Name: Levodopa without any DDCI (galenic formulation)
Placebo Comparator: Placebo
Powder of groundnuts
- Magnitude of motor response [ Time Frame: up to 3 hours ]Percentage of change in UPDRS motor score (part III) from baseline (overnight OFF state) to 90 minutes and 180 minutes after acute intake (full ON state)
- ON duration [ Time Frame: up to 6 hours ]Duration of full ON state after acute intake
- Latency to ON [ Time Frame: up to 6 hours ]Latency in minutes between the acute intake (at the overnight OFF state) and the ON state
- Severity of dyskinesias [ Time Frame: up to 3 hours ]Severity of dyskinesias after acute intake, as assessed by the abnormal involuntary movements scale (AIMS) at 90 minutes and 180 minutes
- Changes in vital signs [ Time Frame: up to 3 hours ]Changes in blood pressure and heart rate at 90 minutes and 180 minutes after acute intake
- Change in mean total daily off-time without troublesome dyskinesias [ Time Frame: 16 weeks ]Change in mean total daily off-time as measured by 24-h diaries during chronic treatment
- Change in quality of life questionnaire scores [ Time Frame: 16 weeks ]Change in quality of life (as assessed by the PDQ-39) during chronic treatment
- Change in Non-Motor Symptoms questionnaire scores [ Time Frame: 16 weeks ]Change in non-motor symptoms (as assessed by the Movement Disorders Society - Non-Motor Symptoms questionnaire) during chronic treatment
- Frequency of spontaneously reported adverse events [ Time Frame: 16 weeks ]Incidence of spontaneously reported adverse events during acute and chronic treatment
- Laboratory indices [ Time Frame: 16 weeks ]Changes in laboratory indices from baseline to week 16
- Electrocardiography [ Time Frame: 16 weeks ]Changes in electrocardiographic measures from baseline to week 16
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680977
|Clinica Niño Jesus|
|Santa Cruz de la Sierra, Bolivia|
|Principal Investigator:||Roberto Cilia, MD||ASST Gaetano Pini-CTO|
|Study Chair:||Gianni Pezzoli, MD||ASST Gaetano Pini-CTO|