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

Last updated: January 29, 2019
Sponsor: Hadassah Medical Organization
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03823638
0346-17-HMO-CTIL
  • Ages 40-75
  • All Genders

Study 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 Criteria

Inclusion

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 bankcriteria diagnosed after the age of 40.

  4. Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit

Exclusion

Exclusion Criteria:

  1. Patients with motor deficits that require administration of symptomatic therapy morethan 4 times per day at the day of visit 1.

  2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deepbrain 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 proceedingat the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed forindication 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 ofchild-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 toconsumption of oral mannitol or glucose.

Study Design

Total Participants: 60
Study Start date:
November 20, 2018
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

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