Clinical trial NCT05106504: Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
Official title: Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder, Overactive
Parkinson Disease
Keywords: non-motor symptoms
Parkinson's disease
Bladder overactivity
Medical cannabis
Cannabidiol
delta-9-tetrahydrocannabinol
pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Non-motor symptoms scale (NMSS)
timeFrame: before and 4-8 weeks after treatment initiation
measure: Change in Bladder over activity symptoms
timeFrame: before and 4-8 weeks after treatment initiation
Secondary outcomes:
measure: Change in sleep quality
timeFrame: before and 4-8 weeks after treatment initiation
measure: Change in subjective Pain
timeFrame: before and 4-8 weeks after treatment initiation
measure: Change in Quality of life
timeFrame: before and 4-8 weeks after treatment initiation
measure: Cannabis strand analysis
timeFrame: 4-8 weeks following treatment initiation
measure: Change in International prostate symptom score (IPSS)
timeFrame: before and 4-8 weeks after treatment initiation
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center, Ramat-Gan, Israel
name: Saar Anis, MD
role: PRINCIPAL_INVESTIGATOR
References: