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Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

NCT ID: NCT05106504

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-02

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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This is a prospective, open-label, observational study. Patients with Parkinson's disease (PD) receiving licensure from Israeli Ministry of Health (MOH) for using medical cannabis (MC) for PD related symptoms and pain, being followed up in the Movement Disorders Institute (MDI) at SHEBA Medical Center (SMC) will be eligible to participate. Assessment regarding patient demographic, disease characteristics (Hoehn and Yahr, disease duration, disease first symptom etc.) will be collected at baseline along with designated questionnaires to evaluate the non-motor symptoms (NMSS, PDSS, Kings PD pain scale, PDQ8) and urinary function (Bladder over activity, International prostate symptom score (IPSS) and nocturia questionnaires). after MC initiation, patients will be observed and evaluated for the impact of MC 4-8 weeks following treatment initiation. Also, for each patient, MC being used will be analyzed in order to expose relationship between phyto-cannabinoid content and efficacy or side effects.

Conditions

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Bladder, Overactive Parkinson Disease

Keywords

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non-motor symptoms Parkinson's disease Bladder overactivity Medical cannabis Cannabidiol delta-9-tetrahydrocannabinol pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's disease patients

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

Medical Cannabis

Intervention Type DRUG

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

Interventions

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Medical Cannabis

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Saar Anis

Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saar Anis, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center, Ramat-Gan, Israel

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Saar Anis, MD

Role: CONTACT

Phone: +972 52 5691650

Email: [email protected]

Omer Anis, MD

Role: CONTACT

Phone: +972 52 8787821

Email: [email protected]

Facility Contacts

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saar anis

Role: primary

Omer Anis, MD

Role: backup

Other Identifiers

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Sheba-20-7553-SA-CTL

Identifier Type: -

Identifier Source: org_study_id