Loading clinical trials...

UNKNOWNPHASE2

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

NCT03823638•Hadassah Medical Organization

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (1)

Hadassah Medical Center

Jerusalem, Israel

Key Dates

Start Date

November 20, 2018

Primary Completion Date

July 1, 2020

Completion Date

December 31, 2020

Last Updated

January 30, 2019

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

Oral D-Mannitol of Placebo

DIETARY_SUPPLEMENT

Contacts

David Arkadir, MD PhD

CONTACT

02-6777716 arkadir@hadassah.org.il

Anna Linetsky

CONTACT

02-6777716 annalin@hadassah.org.il

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients