NCT05106504

Brief Summary

Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

October 16, 2021

Last Update Submit

October 29, 2021

Conditions

Bladder, OveractiveParkinson Disease

Keywords

non-motor symptomsParkinson's diseaseBladder overactivityMedical cannabisCannabidioldelta-9-tetrahydrocannabinolpain

Outcome Measures

Primary Outcomes (2)

  • Change in Non-motor symptoms scale (NMSS)

    NMSS will be assessed before and after medical cannabis use, range 0-360, higher scores mean a worse outcome

    before and 4-8 weeks after treatment initiation

  • Change in Bladder over activity symptoms

    Overactive Bladder Symptom Score (OABSS) questionnaires will be assessed before and after medical cannabis use, range 0-15, higher scores mean a worse outcome

    before and 4-8 weeks after treatment initiation

Secondary Outcomes (5)

  • Change in sleep quality

    before and 4-8 weeks after treatment initiation

  • Change in subjective Pain

    before and 4-8 weeks after treatment initiation

  • Change in Quality of life

    before and 4-8 weeks after treatment initiation

  • Cannabis strand analysis

    4-8 weeks following treatment initiation

  • Change in International prostate symptom score (IPSS)

    before and 4-8 weeks after treatment initiation

Study Arms (1)

Parkinson's disease patients

Parkinson's disease patients receiving medical cannabis for pain related to the disease

Drug: Medical Cannabis

Interventions

Medical CannabisDRUG

Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract

Parkinson's disease patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current study population include PD patients, males and females, aged 18-80, with a license to use Medical cannabis for PD related symptoms, newly issued or, with no recent use.

You may qualify if:

  • Diagnosis of Parkinson's disease according to UK Parkinson's disease society barin bank clinical diagnostic criteria
  • Holds a validated Medical cannabis license, from Israeli Ministry of health
  • Able to sign informed consent
  • Age 18-80

You may not qualify if:

  • Use of Medical cannabis in the previous 30 days prior to study recruitment visit
  • Concomitent severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia.
  • Cannot sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, OveractiveParkinson DiseasePain

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Saar Anis, MD

    Sheba Medical Center, Ramat-Gan, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saar Anis, MD

CONTACT

+972 52 5691650saaranis@gmail.com

Omer Anis, MD

CONTACT

+972 52 8787821omerwn@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center

Study Record Dates

First Submitted

October 16, 2021

First Posted

November 3, 2021

Study Start

September 2, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

November 3, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)