Mucuna Pruriens Therapy in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02680977
• Date of registration: 09/02/2016
• Prospective Registration: No
• Primary sponsor: ASST Gaetano Pini-CTO
• Public title: Mucuna Pruriens Therapy in Parkinson's Disease
• Scientific title: Mucuna Pruriens Therapy in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomized, Crossover Study.
• Date of first enrolment: February 2016
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02680977
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bolivia

Contacts

• Name: Roberto Cilia, MD
• Affiliation: ASST Gaetano Pini-CTO

• Name: Gianni Pezzoli, MD
• Affiliation: ASST Gaetano Pini-CTO

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: MP+DDCI

Other: Placebo

Drug: LD-DDCI

Other: MP-Low

Drug: LD+DDCI

Other: MP-Equivalent

Primary Outcome(s)

Magnitude of motor response [Time Frame: up to 3 hours]

Secondary Outcome(s)

ON duration [Time Frame: up to 6 hours]

Severity of dyskinesias [Time Frame: up to 3 hours]

Change in quality of life questionnaire scores [Time Frame: 16 weeks]

Frequency of spontaneously reported adverse events [Time Frame: 16 weeks]

Changes in vital signs [Time Frame: up to 3 hours]

Laboratory indices [Time Frame: 16 weeks]

Change in Non-Motor Symptoms questionnaire scores [Time Frame: 16 weeks]

Electrocardiography [Time Frame: 16 weeks]

Change in mean total daily off-time without troublesome dyskinesias [Time Frame: 16 weeks]

Latency to ON [Time Frame: up to 6 hours]

Secondary ID(s)

SBN.SC.013/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondazione Grigioni per il Morbo di Parkinson