Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.

Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment.
Following treatment with placebo, all participants in this group will begin treatment with medical cannabis.

Drug Resistant Epilepsy

The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.

Medical Cannabis

The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.

Placebo

University Hospital Campus, London Health Sciences Centre

University Health Network - Toronto Western Hospital

Cannabis Extract in Refractory Epilepsy Study

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures

QOLIE-31 is a 31-item measure assessing health-related quality of life in adults with epilepsy. Seven scales assess seizure worry, overall quality of life, emotional well-being, cognitive and medication effects, and social function.

WHOQOL-BREF is a 26-item measure of physical health, psychological health, social relationships, and environment.

QOLCE is a 55-item scale assessing health-related quality of life in children with epilepsy from the perspective of the parent or caregiver. It covers cognitive, emotional, social, and physical functioning.

NDDI-E is a 6-item questionnaire designed to screen for depression in adults with epilepsy.

QIDS is a 16-item measure designed to assess the severity of depressive symptoms.

GAD-7 is a 7-item questionnaire assessing severity of generalized anxiety disorder.

GASE is a single-item, 7-point global rating scale that was designed to assess the overall severity of epilepsy.

PSQI is a 19-item measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction.

PGIC is a 7-point scale assessing the patient's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

CGIC is a 7-point scale assessing the caregiver's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

BSI-53 is a 53-item measure assessing psychological profiles. It covers 9 primary domains: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.

SDS is a 5-item measure assessing functional impairment in three inter-related domains: work/school, social, and family life.

The Epilepsy Research Program of the Ontario Brain Institute

Ontario Brain Institute

University of Toronto

University Health Network, Toronto

London Health Sciences Centre

MedReleaf

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.

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.

all participants will be in this arm and will receive study drug 'Cannabidiol-Rich whole Plant Extract (TIL-TC150) to assess dosing and tolerability according to study protocol

Epilepsy

The active ingredients in TIL-TC150 are tetrahydrocannabinol (THC) and Cannabidiol (CBD), isolated from the Cannabis sativa L. strains produced by Tilray, and formulated into an oral liquid drug product.

TIL-TC150

The Hospital for Sick Children

Cannabinoid Therapy for Pediatric Epilepsy

Cannabinoid Therapy in Medically Refractory Pediatric Epilepsy - Phase 1: Dosing and Tolerability Study of a Cannabidiol-Rich Whole Plant Extract of Cannabis.

During this study, the dose of TIL-TC150 will be titrated according to study protocol and participant tolerance. Tolerance will be assessed as documented in title, by evaluating for adverse events clinically and by parent report of adverse event every week during the first 20 weeks of the study, also by blood work at weeks 0, 4, and between 8-16 weeks.
For those choose to continue the study drug after 20 week period of assessment, tolerance will be evaluated by assessing for adverse events at weeks 28, 40,52 and 64.

During this study, tolerance will also be assessed by the standardised side effects questionnaire- PESQ in clinic at weeks 2,4,8,12 and 16. For those choosing to continue therapy will be reassessed by PESQ in clinic at week 28,40,52 and 64.

The QOLCE will be completed by parents at clinic at first visit or baseline(week 0), at maximal dose (8 weeks) and at 16 weeks for primary analysis. For those choosing to continue therapy will be reassessed at 28 weeks and 52 weeks. Parents will be provided with a research report detailing the assessment findings at study completion.

Vineland Adaptive Behaviour Scale, Second Edition: is a standardized parent interview to complete either in person at the clinic or by telephone on week 0, prior to starting the TIL-TC150. The interview will also be completed again at the primary evaluation period anytime between weeks 16 and 20 and again for those choosing to continue the therapy will be reassessed during the longitudinal follow-up anytime between 52 and 64 weeks. This will be done by study team. Parents will be provided with a research report detailing the assessment findings at study completion.

Carter Snead

Principal Investigator

Tilray

Pediatric epilepsy patients who are followed at Children's Hospital Colorado with medically refractory epilepsy, and whom the family has decided to treat with medical cannabis.

Epilepsy, Unspecified, Refractory (Medically)

Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.

More information about medical marijuana research at childrens hospital colorado

Children's Hospital Colorado

The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy

Prolonged EEG recordings lasting 24-48 hours (whichever is clinically indicated) will be performed in either the home setting as an ambulatory EEG or in the hospital in the Epilepsy Monitoring Unit. This decision will be made on a clinical basis. This will allow for objective quantification of seizures in children with frequent seizures that occur on a daily basis and background EEG changes for other children. Two EEGs will be done: one at baseline, and one at the end of the study.

Each subject will maintain a seizure diary. Rescue drug use and VNS (Vagus Nerve Stimulation) activations will be tracked as an adjunct to all current anti-seizure medications. Frequency of status epilepticus will be tracked as well as hospital visits for seizures or adverse events from MCBD. Clinical evaluations will be taken every 2 months throughout the duration of the study. Subjects will be monitored every 2 weeks by telephone and/or email.

Side effects will be evaluated using PESQ (Pediatric epilepsy Side Effects Questionnaire). This questionnaire will be administered 4 weeks, 8 weeks, and 12 weeks after baseline.

University of Colorado, Denver

Colorado Department of Public Health and Environment

Quetiapine + Placebo
quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quitiapine + Placebo

Quetiapine + Topiramate
Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Quetiapine + Topiramate

Total

Sex: Female, Male

Region of Enrollment

Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.

Quetiapine and Placebo
Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quitiapine and Placebo

Quetiapine and Topiramate
Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Quetiapine and Topiramate

Change in Joints Per Week

Change in percent days of cannabis use per week from baseline to week 16.

Change in Percent Days of Cannabis Use Per Week

Overall Study

Melissa P. DelBello, MD

Bipolar Disorder

Cannabis-Related Disorder

placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine and placebo

topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

epilepsy/cannabis

Cannabis Extract in Refractory Epilepsy Study

Cannabis Oil for Pain in Parkinson's Disease

Cannabinoid Therapy for Pediatric Epilepsy

The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy

Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

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