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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D-Mannitol

Oral Supplement of the investigated substance: D-Mannitol powder (manufacturer Roquette)

Group Type EXPERIMENTAL

Oral D-Mannitol of Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Oral Supplement of the placebo: Dextrose monohydrate powder (manufacturer Roquette)

Group Type PLACEBO_COMPARATOR

Oral D-Mannitol of Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Oral D-Mannitol of Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Ability to understand and signing of informed consent form.
2. Age 40-75 years at the day of visit 1.
3. Diagnosis of Parkinson's disease that is based on the United Kingdom brain bank criteria diagnosed after the age of 40.
4. Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit 1.

Exclusion Criteria

1. Patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1.
2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion).
3. Patients with dementia reflected by a Mini-mental state examination (MoCA) ≥ 24.
4. Patient with legal guardian.
5. History of psychosis or use of dopamine receptor blocking agent on the year proceeding at the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed for indication other than psychosis is allowed.
6. Suspected Parkinsonian syndrome other than Parkinson's disease.
7. Use of medical marihuana on the month proceeding visit 1.
8. Pregnant or lactating women, or fertile woman who does not use contraceptive. Woman of child-bearing potential must have a negative urine Human chorionic gonadotropin (hCG) and will be monitored by repeated urine tests.
9. Patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit).
10. Diabetes mellitus.
11. Clinical evidence for congestive heart failure.
12. Patient with symptomatic orthostatic hypotension.
13. Based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No