Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
1 other identifier
interventional
38
1 country
1
Brief Summary
This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease. The principal objective is to evaluate the changes in biomarkers of oxidative stress and,plasma amino acids, as well as improvement of clinical symptoms and brain function
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 parkinson-disease
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 30, 2013
September 1, 2013
1.7 years
August 7, 2012
September 27, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
6 months
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
6 months
Secondary Outcomes (6)
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
6 months
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
6 months
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
6 months
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
6 months
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
6 months
- +1 more secondary outcomes
Study Arms (2)
HMS 90®
ACTIVE COMPARATORPlacebo (Soy protein)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with Idiopathic Parkinson's Disease
- Subjects who are willing and able to participate in the trial and has provided written, informed consent.
You may not qualify if:
- Subjects who are allergic to Whey protein (HMS 90®).
- Subjects who are treated with chemotherapy .
- Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
- Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chulalongkorn University Hospital
Pathumwan, Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roongroj Bhidayasiri, MD
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 10, 2012
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 30, 2013
Record last verified: 2013-09