A Phase 2 interventional study of Oral D-Mannitol of Placebo in Parkinson Disease, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Hadassah Medical Organization · Phase 2, Interventional, and Treatment
Parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. Currently, no disease-modifying therapy exists for this disease. Mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. In this phase II, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with Parkinson's disease for 36 weeks.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Oral Supplement of the investigated substance: D-Mannitol powder (manufacturer Roquette)
Dietary Supplement: Oral D-Mannitol of Placebo
Oral Supplement of the placebo: Dextrose monohydrate powder (manufacturer Roquette)
Dietary Supplement: Oral D-Mannitol of Placebo
Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)
Safety of oral mannitol in Parkinson's disease as assessed by the number of mannitol-related adverse events, clinically significant changes in vital signs and clinically significant abnormalities in laboratory results.
Safety will be assessed by the number of treatment-related adverse events, number of patients with clinically significant change of vital signs (supine and standing blood pressure and pulse) and number of patients with clinically significant change in laboratory results (electrolytes, renal and liver functions, blood count).
Time frame: 36 weeks
Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams) of mannitol that does not cause discomfort.
Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams, up to 18 grams per day) of mannitol that does not cause discomfort based on the subjective report by the patient.
Time frame: 36 weeks
Time-interval for starting symptomatic therapy (in days) between baseline and week 36, in patients not receiving symptomatic therapy at baseline.
Median time interval will be reported. P-Values as assessed by Mann-Whitney test will be reported. Longer time interval will be considered as a better outcome.
Time frame: 36 weeks
Change in levodopa-equivalent dose units between baseline and week 36.
Total levodopa-equivalent dose (LED units) will be calculated based on Tomlinson, Mov Disord 2010. P-Values as assessed by Mann-Whitney test will be reported. Smaller change will be considered as a better outcome.
Time frame: 36 weeks
Change of Brief Smell Identification Test (B-SIT) score between baseline and week 36.
Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value (reflecting improved smell) or lower absolute negative value (slower deterioration) will be considered as better outcomes.
Time frame: 36 weeks
Change in constipation assesment (CAS) score between baseline and week 36.
Median and range of change will be reported. Change in score will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes.
Time frame: 36 weeks
Change in Montreal Cognitive Assessment (MoCA) test score between baseline and week 36.
P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes.
Time frame: 36 weeks
Change in non-motor symptoms of Parkinson's disease scale (NMSS) between baseline and week 36.
Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes.
Time frame: 36 weeks
Change in the ratio of total-to-proteinase K-resistant α-synuclein in red blood cells (RBC) measured by enzyme-linked immunosorbent assay (ELISA)between baseline and week 36.
Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes.
Time frame: 36 weeks
Plan to share: No
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization