Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-26 @ 6:53 PM
Study NCT ID:
NCT05106504
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064086', 'term': 'Medical Marijuana'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2021-10-16', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Non-motor symptoms scale (NMSS)', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'NMSS will be assessed before and after medical cannabis use, range 0-360, higher scores mean a worse outcome'}, {'measure': 'Change in Bladder over activity symptoms', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'Overactive Bladder Symptom Score (OABSS) questionnaires will be assessed before and after medical cannabis use, range 0-15, higher scores mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Change in sleep quality', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome'}, {'measure': 'Change in subjective Pain', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'Kings PD pain scale will be employed before and after MC use, range 0-168 , higher scores mean a worse outcome'}, {'measure': 'Change in Quality of life', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome'}, {'measure': 'Cannabis strand analysis', 'timeFrame': '4-8 weeks following treatment initiation', 'description': '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'}, {'measure': 'Change in International prostate symptom score (IPSS)', 'timeFrame': 'before and 4-8 weeks after treatment initiation', 'description': 'IPSS will be assessed before and after medical cannabis use, range 0-35, higher scores mean a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-motor symptoms', "Parkinson's disease", 'Bladder overactivity', 'Medical cannabis', 'Cannabidiol', 'delta-9-tetrahydrocannabinol', 'pain'], 'conditions': ['Bladder, Overactive', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to UK Parkinson's disease society barin bank clinical diagnostic criteria\n* Holds a validated Medical cannabis license, from Israeli Ministry of health\n* Able to sign informed consent\n* Age 18-80\n\nExclusion Criteria:\n\n* Use of Medical cannabis in the previous 30 days prior to study recruitment visit\n* Concomitent severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia.\n* Cannot sign informed consent"}, 'identificationModule': {'nctId': 'NCT05106504', 'briefTitle': "Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': "Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Sheba-20-7553-SA-CTL'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease patients", 'description': "Parkinson's disease patients receiving medical cannabis for pain related to the disease", 'interventionNames': ['Drug: Medical Cannabis']}], 'interventions': [{'name': 'Medical Cannabis', 'type': 'DRUG', 'description': 'Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract', 'armGroupLabels': ["Parkinson's disease patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'saar anis', 'role': 'CONTACT', 'email': 'saaranis@gmail.com', 'phone': '+972 52 5691650'}, {'name': 'Omer Anis, MD', 'role': 'CONTACT', 'email': 'omerwn@gmail.com', 'phone': '+972 52 8787821'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Saar Anis, MD', 'role': 'CONTACT', 'email': 'saaranis@gmail.com', 'phone': '+972 52 5691650'}, {'name': 'Omer Anis, MD', 'role': 'CONTACT', 'email': 'omerwn@gmail.com', 'phone': '+972 52 8787821'}], 'overallOfficials': [{'name': 'Saar Anis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center, Ramat-Gan, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center', 'investigatorFullName': 'Dr. Saar Anis', 'investigatorAffiliation': 'Sheba Medical Center'}}}}