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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106504
• Other study ID #: Sheba-20-7553-SA-CTL
• Status: Recruiting
• Start date: September 2, 2021
• Est. completion date: August 2024

Study information

• Verified date: October 2021
• Source: Sheba Medical Center
• Contact: Saar Anis, MD
• Phone: +972 52 5691650
• Email: saaranis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder, Overactive
• Marijuana Abuse
• Parkinson Disease
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in sleep quality	PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome	before and 4-8 weeks after treatment initiation
Secondary	Change in subjective Pain	Kings PD pain scale will be employed before and after MC use, range 0-168 , higher scores mean a worse outcome	before and 4-8 weeks after treatment initiation
Secondary	Change in Quality of life	PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome	before and 4-8 weeks after treatment initiation
Secondary	Cannabis strand analysis	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	4-8 weeks following treatment initiation
Secondary	Change in International prostate symptom score (IPSS)	IPSS will be assessed before and after medical cannabis use, range 0-35, higher scores mean a worse outcome	before and 4-8 weeks after treatment initiation