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Safety, Tolerability and Effects of Mannitol in Parkinson's Disease

NCT03823638 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

DIETARY_SUPPLEMENT

Oral D-Mannitol of Placebo

Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-07-01
Completion
2020-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823638 on ClinicalTrials.gov