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

• Conditions: Bladder, Overactive; Parkinson Disease
• Interventions: Drug: Medical Cannabis

• Registration Number: NCT05106504
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-09-02
• Status Verified: 2021-10
• Study First Submitted: 2021-10-16
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's disease patients	Medical Cannabis	Parkinson's disease patients receiving medical cannabis for pain related to the disease

Primary Outcome Measures

Name	Time	Method
Change in Bladder over activity symptoms	before and 4-8 weeks after treatment initiation	Overactive Bladder Symptom Score (OABSS) questionnaires will be assessed before and after medical cannabis use, range 0-15, higher scores mean a worse outcome
Change in Non-motor symptoms scale (NMSS)	before and 4-8 weeks after treatment initiation	NMSS will be assessed before and after medical cannabis use, range 0-360, higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Change in subjective Pain	before and 4-8 weeks after treatment initiation	Kings PD pain scale will be employed before and after MC use, range 0-168 , higher scores mean a worse outcome
Change in Quality of life	before and 4-8 weeks after treatment initiation	PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome
Cannabis strand analysis	4-8 weeks following treatment initiation	Cannabinoid content within products being used by our patient will be analyzed. Correlation between efficacy and side effect profile to MC cannabinoid content will be employed
Change in sleep quality	before and 4-8 weeks after treatment initiation	PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome
Change in International prostate symptom score (IPSS)	before and 4-8 weeks after treatment initiation	IPSS will be assessed before and after medical cannabis use, range 0-35, higher scores mean a worse outcome

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel