Bladder, OveractiveNCT05106504
Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
An observational study of Bladder, Overactive and Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder, Overactive, Parkinson Disease
- What is being tested?
- Medical Cannabis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Sep 2021to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
saar anis, +972 52 5691650, saaranis@gmail.com
Omer Anis, MD, +972 52 8787821, omerwn@gmail.com
About this study
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.
Read the 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.
- Conditions
- Bladder, Overactive, Parkinson Disease
- Being tested
- Medical Cannabis
- Keywords
- non-motor symptoms, Parkinson's disease, Bladder overactivity, Medical cannabis, Cannabidiol, delta-9-tetrahydrocannabinol, pain
- Medical subject headings
- Urinary Bladder, Overactive, Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients receiving medical cannabis for pain related to the disease Receives: Drug: Medical Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and 4-8 weeks after treatment initiation
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
Measured: before and 4-8 weeks after treatment initiation
Secondary outcomes (5)
Change in sleep quality
PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome
Measured: before and 4-8 weeks after treatment initiation
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
Measured: before and 4-8 weeks after treatment initiation
Change in Quality of life
PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome
Measured: before and 4-8 weeks after treatment initiation
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
Measured: 4-8 weeks following treatment initiation
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
Measured: before and 4-8 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start2 Sep 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Saar Anis, Sheba Medical Center
- Investigators
- Saar Anis, MD, Principal investigator, Sheba Medical Center, Ramat-Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106504
- Sponsor's protocol ID
- Sheba-20-7553-SA-CTL
- Status last verified
- Oct 2021
- First submitted
- 16 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05106504
- Acronym / sponsor ID
- Sheba-20-7553-SA-CTL
- Conditions
- Bladder, Overactive, Parkinson Disease
- Keywords
- non-motor symptoms, Parkinson's disease, Bladder overactivity, Medical cannabis, Cannabidiol, delta-9-tetrahydrocannabinol, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Drug: Medical CannabisParkinson's disease patients receiving medical cannabis for pain related to the disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisPatients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract | Drug | Parkinson's disease patients |
Primary outcome
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
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
5 secondary outcomes
Change in sleep quality
Time frame: before and 4-8 weeks after treatment initiation
Change in subjective Pain
Time frame: before and 4-8 weeks after treatment initiation
Change in Quality of life
Time frame: before and 4-8 weeks after treatment initiation
Cannabis strand analysis
Time frame: 4-8 weeks following treatment initiation
Change in International prostate symptom score (IPSS)
Time frame: before and 4-8 weeks after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Bladder, Overactive
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saar Anis, MD principal investigator
Sheba Medical Center, Ramat-Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder, Overactive and Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saar Anis, MD (+972 52 5691650, saaranis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-motor symptoms scale (NMSS) (time frame: before and 4-8 weeks after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.