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Mucuna Pruriens Therapy in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02680977
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Fondazione Grigioni per il Morbo di Parkinson
Information provided by (Responsible Party):
Roberto Cilia, ASST Gaetano Pini-CTO

Brief 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.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
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)

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 Name: Mucuna pruriens at equivalent 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 Name: Mucuna pruriens at low dosage

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.
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.

Drug: LD+DDCI
Levodopa plus Benserazide
Other Name: Madopar

Drug: LD-DDCI
Levodopa without any DDCI
Other Name: Levodopa without any DDCI (galenic formulation)

Placebo Comparator: Placebo
Powder of groundnuts
Other: Placebo
Groundnuts powder




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. ON duration [ Time Frame: up to 6 hours ]
    Duration of full ON state after acute intake

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Frequency of spontaneously reported adverse events [ Time Frame: 16 weeks ]
    Incidence of spontaneously reported adverse events during acute and chronic treatment

  9. Laboratory indices [ Time Frame: 16 weeks ]
    Changes in laboratory indices from baseline to week 16

  10. Electrocardiography [ Time Frame: 16 weeks ]
    Changes in electrocardiographic measures from baseline to week 16



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Bolivia
Clinica Niño Jesus
Santa Cruz de la Sierra, Bolivia
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Fondazione Grigioni per il Morbo di Parkinson
Investigators
Principal Investigator: Roberto Cilia, MD ASST Gaetano Pini-CTO
Study Chair: Gianni Pezzoli, MD ASST Gaetano Pini-CTO

Study Data/Documents: Laboratory analysis (preliminary to clinical study)  This link exits the ClinicalTrials.gov site
This study (currently submitted) describes the aims and results of laboratory testing on several different ecotypes of Mucuna pruriens, including the Bolivian variety to be used in the present protocol

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto Cilia, Neurologist, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02680977     History of Changes
Other Study ID Numbers: SBN.SC.013/2015
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Roberto Cilia, ASST Gaetano Pini-CTO:
Mucuna pruriens
Levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Benserazide
Benserazide, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors