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Safety, Tolerability and Effects of Mannitol in Parkinson's Disease (PD-mannitol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823638
Recruitment Status : Unknown
Verified January 2019 by ARKADIR DAVID, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
ARKADIR DAVID, Hadassah Medical Organization

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: Oral D-Mannitol of Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arms and Interventions
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Arm Intervention/treatment
Experimental: D-Mannitol
Oral Supplement of the investigated substance: D-Mannitol powder (manufacturer Roquette)
 Dietary Supplement: Oral D-Mannitol of Placebo
Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)
Placebo Comparator: Placebo
Oral Supplement of the placebo: Dextrose monohydrate powder (manufacturer Roquette)
 Dietary Supplement: Oral D-Mannitol of Placebo
Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)


Outcome Measures
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Primary Outcome Measures :
  1. Safety of oral mannitol in Parkinson's disease as assessed by the number of mannitol-related adverse events, clinically significant changes in vital signs and clinically significant abnormalities in laboratory results. [ Time Frame: 36 weeks ]
    Safety will be assessed by the number of treatment-related adverse events, number of patients with clinically significant change of vital signs (supine and standing blood pressure and pulse) and number of patients with clinically significant change in laboratory results (electrolytes, renal and liver functions, blood count).

  2. Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams) of mannitol that does not cause discomfort. [ Time Frame: 36 weeks ]
    Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams, up to 18 grams per day) of mannitol that does not cause discomfort based on the subjective report by the patient.


Secondary Outcome Measures :
  1. Time-interval for starting symptomatic therapy (in days) between baseline and week 36, in patients not receiving symptomatic therapy at baseline. [ Time Frame: 36 weeks ]
    Median time interval will be reported. P-Values as assessed by Mann-Whitney test will be reported. Longer time interval will be considered as a better outcome.

  2. Change in levodopa-equivalent dose units between baseline and week 36. [ Time Frame: 36 weeks ]
    Total levodopa-equivalent dose (LED units) will be calculated based on Tomlinson, Mov Disord 2010. P-Values as assessed by Mann-Whitney test will be reported. Smaller change will be considered as a better outcome.

  3. Change of Brief Smell Identification Test (B-SIT) score between baseline and week 36. [ Time Frame: 36 weeks ]
    Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value (reflecting improved smell) or lower absolute negative value (slower deterioration) will be considered as better outcomes.

  4. Change in constipation assesment (CAS) score between baseline and week 36. [ Time Frame: 36 weeks ]
    Median and range of change will be reported. Change in score will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes.

  5. Change in Montreal Cognitive Assessment (MoCA) test score between baseline and week 36. [ Time Frame: 36 weeks ]
    P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes.

  6. Change in non-motor symptoms of Parkinson's disease scale (NMSS) between baseline and week 36. [ Time Frame: 36 weeks ]
    Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes.

  7. Change in the ratio of total-to-proteinase K-resistant α-synuclein in red blood cells (RBC) measured by enzyme-linked immunosorbent assay (ELISA)between baseline and week 36. [ Time Frame: 36 weeks ]
    Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823638


Contacts
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Contact: David Arkadir, MD PhD 02-6777716 arkadir@hadassah.org.il
Contact: Anna Linetsky 02-6777716 annalin@hadassah.org.il

Locations
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Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: David Arkadir, MD PhD    02-6777716    arkadir@hadassah.org.il   
Contact: Anna Linetsky    02-6777716    annalin@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Responsible Party: ARKADIR DAVID, Principal Investigator, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03823638    
Other Study ID Numbers: 0346-17-HMO-CTIL
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Synucleinopathies
Neurodegenerative Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs