Trials / Unknown
UnknownNCT03823638
Safety, Tolerability and Effects of Mannitol in Parkinson's Disease
A Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's Disease
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hadassah Medical Organization · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Oral D-Mannitol of Placebo | Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate) |
Timeline
- Start date
- 2018-11-20
- Primary completion
- 2020-07-01
- Completion
- 2020-12-31
- First posted
- 2019-01-30
- Last updated
- 2019-01-30
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT03823638. Inclusion in this directory is not an endorsement.