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

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ClinicalTrials.gov Identifier: NCT05106504
Recruitment Status : Recruiting
First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Saar Anis, 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.

Condition or disease Intervention/treatment
Bladder, Overactive Parkinson Disease Drug: Medical Cannabis

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
Actual Study Start Date : September 2, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease patients
Parkinson's disease patients receiving medical cannabis for pain related to the disease
Drug: Medical Cannabis
Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract




Primary Outcome Measures :
  1. Change in Non-motor symptoms scale (NMSS) [ Time Frame: 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

  2. Change in Bladder over activity symptoms [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in sleep quality [ Time Frame: 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

  2. Change in subjective Pain [ Time Frame: 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

  3. Change in Quality of life [ Time Frame: 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

  4. Cannabis strand analysis [ Time Frame: 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

  5. Change in International prostate symptom score (IPSS) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05106504


Contacts
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Contact: Saar Anis, MD +972 52 5691650 saaranis@gmail.com
Contact: Omer Anis, MD +972 52 8787821 omerwn@gmail.com

Locations
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Israel
Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: saar anis    +972 52 5691650    saaranis@gmail.com   
Contact: Omer Anis, MD    +972 52 8787821    omerwn@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Saar Anis, MD Sheba Medical Center, Ramat-Gan, Israel
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Responsible Party: Dr. Saar Anis, Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT05106504    
Other Study ID Numbers: Sheba-20-7553-SA-CTL
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Saar Anis, Sheba Medical Center:
non-motor symptoms
Parkinson's disease
Bladder overactivity
Medical cannabis
Cannabidiol
delta-9-tetrahydrocannabinol
pain
Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder, Overactive
Marijuana Abuse
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations