Parkinson Disease

Mixed oil cannabis preparation consisting of 3 differing formulations of ∆-9THC and CBD is clinically available in Canada as CanniMed®. The 3 differing formulations of CanniMed® oils contain varying proportions of ∆-9THC and CBD in the following ratios: 18:0; 10:10; 1:20.
All CanniMed® oil formulations consist of cannabinoids extracted from dried cannabis, and diluted in olive oil.

Cannabis Oil

HealthCanada. Information for Health Care Professionals. Cannabis (marihuana, marijuana) and the cannabinoids

Cannabis Oil for Pain in Parkinson's Disease

A Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's Disease

MTD will be defined as the dose of each CanniMed® preparation for which the subject was able to be on for a minimum of 1 week, without the occurrence of an AE or suspected AE, with the severity grading of 2 or higher (CTCAE v.4.0)

Determine the incidence and severity of adverse events by direct patient questioning, physical examination and ancillary testing as per protocol

KPPS is a validated, disease-specific scale with seven domains (different types of pain) including 14 items, each item scored by severity (0-3) multiplied by frequency (0-4) with a total possible score range from 0 to 168.

The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

The score assesses the motor signs of PD and ranges between 0-137.

The scale is divided in 2 parts. Part 2A is administered by the rater (one question) and focuses on time spent with off-dystonia. Part 2B is a component of the Patient Questionnaire that covers three questions on the impact of painful off-dystonia on experiences of daily living. The score ranges between 0-16.

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24.

University Health Network, Toronto

Parkinson Society Canada

This is an interventional, phase II, randomized, open-label, double-blind, two-centre study to evaluate the safety, tolerability, and dose-finding of Cannabis oil preparation for pain in Parkinson's disease.
Mixed oil cannabis preparation consisting of 3 differing formulations of ∆-9THC and CBD is clinically available in Canada as CanniMed®. The 3 differing formulations of CanniMed® oils contain varying proportions of ∆-9THC and CBD in the following ratios: 18:0; 10:10; 1:20. A total of 15 patients will be block randomized to one of the three groups. Each patient will receive one formulation of CanniMed® Oil only, with 5 patients per group.

This will be a double-blind study. The different cannabis oil formulations have the same colour, taste and smell. Study investigators will be blind to the dose/formulation of cannabis oil. Unblinding will only be performed in the event of a Serious AE. The site PI will maintain a randomization list kept in a locked secure 24h a day accessible location for emergency unblinding.

Patients start receiving a dose of 0.5 mg daily oral nabilone the first 2 weeks and then 1 mg to complete 8 weeks.

Patients start receiving a dose of 0.5 mg daily oral placebo the first 2 weeks and then 1 mg to complete 8 weeks.

Non-Small Cell Lung Cancer

Anorexia

Cachexia

Weight Lose

Patients going to take 0.5 mg capsules of nabilone (CESAMET) the first 2 weeks and then increased to 1 mg to complete 8 weeks.

Nabilone

Patients going to take capsules of placebo until complete 8 weeks.

Placebo

Instituto Nacional de Cancerologia

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Patients With Anorexia Associated With Advanced Lung Cancer: Randomized Double Blind Clinical Trial

Lack of desire to eat food. Will be obtained through a questionnaire Anorexia / Cachexia scale from Functional Assessment of Anorexia Cachexia Therapy (FAACT) (score ≤24 diagnosis of anorexia)

It is an index of a person's weight in relation to height

convenient, fast and cheaper method used to make a nutritional assessment, consisting of 3 parts: anamnesis, physical examination and qualification.

Total calories consumed on average per day for a subject

Total protein grams consumed on average per day for a subject

Total lipids grams consumed on average per day for a subject

Total carbohydrate grams consumed on average per day for a subject

adverse effect from Common terminology criteria for adverse event

The Global status of Quality of Life evaluation is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer with the items 29 and 30.

The Physical functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The Role functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The Emotional Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The Social Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The Nausea/Vomiting evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The Fatigue evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

The appetite loss evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

Oscar Gerardo Arrieta Rodríguez MD

MD M Sc

Instituto Nacional de Cancerologia de Mexico

Fibromyalgia

Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.

Rehabilitation Hospital

A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable

Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded

Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold

Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.

nabilone/cáncer

Cannabis Oil for Pain in Parkinson's Disease

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients

A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

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