Status:
UNKNOWN
Safety, Tolerability and Effects of Mannitol in Parkinson's Disease
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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 natur...
Eligibility Criteria
Inclusion
- Ability to understand and signing of informed consent form.
- Age 40-75 years at the day of visit 1.
- Diagnosis of Parkinson's disease that is based on the United Kingdom brain bank criteria diagnosed after the age of 40.
- Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit 1.
Exclusion
- Patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1.
- Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion).
- Patients with dementia reflected by a Mini-mental state examination (MoCA) ≥ 24.
- Patient with legal guardian.
- 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.
- Suspected Parkinsonian syndrome other than Parkinson's disease.
- Use of medical marihuana on the month proceeding visit 1.
- 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.
- Patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit).
- Diabetes mellitus.
- Clinical evidence for congestive heart failure.
- Patient with symptomatic orthostatic hypotension.
- Based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03823638
Start Date
November 20 2018
End Date
December 31 2020
Last Update
January 30 2019
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120