Nervous System Diseases

All Conditions

Behaviors and Mental Disorders

Substance Related Disorders

Epilepsy

Neurodevelopmental Disorders

Marijuana Abuse

Mental Disorders

Psychotic Disorders

For children with epilepsy, the following tools will be added for data collection at each time point:

* Side effects: Pediatric Epilepsy Side Effects Questionnaire \[PESQ\]
* Seizure frequency/severity: Seizure Diary Data Questionnaire

For children with cancer, the following tools will be added for data collection at each time point:

* Cancer symptom burden: Symptom Screening in Pediatrics Tool \[SSPedi\]
* Cachexia: Pediatric Functional Assessment of Anorexia/ Cachexia Treatment \[peds-FAACT\]

There are no specific outcome scales added for this cohort.

Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.

Medical Cannabis

Lauren E Kelly, PhD

Lauren Kelly, PhD

Sapna Oberoi, MD

Taylor Lougheed, MD

Evan Lewis, MD

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood, behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or cancer-treatment are eligible to join this 24-month study if they have a valid MC authorization.

Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.

Real World Evidence on the Use of Medical Cannabis in Pediatrics

Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study

summary level data will be available upon reasonable request with appropriate approval and oversight of a research ethics board.

Describe patterns of cannabis use are described using a standard data collection form including dose and product type completed by caregivers at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months

Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary

Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE

Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales

Longitudinal assessment of cachexia using Peds-FAACT

Cannabis-related adverse events and serious adverse events reported by caregivers using a standard AE data collection tool and categorized according to CTCAE v5.0 at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months

Longitudinal assessment of cachexia using PedsQL

PROMIS short form scales for pediatric anxiety symptoms 8a v2.0

PROMIS short form scales for pediatric depression symptoms 8a v2.0

PROMIS short form pediatric positive affect scale 8a v2.0

PROMIS short form pediatric sleep related impairment scale 8a v2.0

PROMIS short form pediatric pain interference scale 8a v2.0

Parents/Caregivers will be asked to report on if their childs behaviour has improved or worsened and will have an open-ended text box to describe anything they want to tell us about changes in their child's behaviour.

The Canadian Collaborative for Childhood Cannabinoid Therapeutics

Canadian Cancer Society (CCS)

Canadian Institutes of Health Research (CIHR)

University of Manitoba

Anticonvulsants

All Drugs and Chemicals

Cannabidiol

High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD.

Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD.

Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD.

High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.

MPL-001

Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.

MPL-005

Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.

MPL-009

Rod Rassekh, MD

Bruce Crooks, MD

Adam Rappoport, MD

CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.

This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.

To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.

All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).

CANnabinoids in Pediatric ONCology

A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial

No. Summary level data may be available from the CAN-PONC steering committee following research ethics board approval.

Pain will be measured using Faces Pain Scale-Revised reported by the participants daily throughout the study. Pain will be reported for each study visit as a percentage change from the weekly average documented at baseline.

Symptom burden is measured using the score of Symptom Screening in Pediatrics Tool (SSPedi) assessed three times a week throughout the study and will be reported as a weekly average and percentage change from baseline.

Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study

Sleep, will be reported as the number of hours per night, measured using Actigraphy and/or parent report, will be reported as an average over a one-week time period.

Symptoms and General Pathology

Cancer Pain

Pain

Nausea

Vomiting

Signs and Symptoms, Digestive

Neurologic Manifestations

Pharmaceutical Solutions

Analgesics

Psychotropic Drugs

Dronabinol

Hallucinogens

Analgesics, Non-Narcotic

Neurotransmitter Agents

Hormones

Hormone Antagonists

Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)

Drug: THC:CBG Oral solution of THC (5 mg/mL) \& CBG (5 mg/mL)

Drug: THC:CBC Oral solution of THC (5 mg/mL) \& CBC (5 mg/mL)

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Aura L Pinzon Galvis, PharmB

Andres Turizo Smith, PharmB

Carlos Rodriguez Martinez, M.D.

Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

This evaluation project of 3 oral formulations of Δ9-THC will be carried out in two phases: Phase I evaluation of bioequivalences in healthy subjects and Phase II evaluation of safety and effectiveness comparing with the reference product (Dronabinol 5mg/mL), formulations derived from cannabis for the management of nausea, vomiting post chemotherapy and exploratory in cancer pain.

Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia

Pharmacokinetics of THC by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) \[ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose \]

Brief pain inventory (BPI); The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."

Drug Effects Questionnaire (DEQ);is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: "Feel Drug", "Feel High", "Like Drug", and "Want More", "dislike the sensation", "any sensations", "feel a head rush", "like drug effect", "dislike any effects". To calculate the DEQ- 'Good Drug Effects'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome

To investigate THC oral formulations in terms of the proportion of patients with no significant nausea (none or mild nausea) following initiation of oral formulations of THC (dronabinol) in post-chemotherapy patients

Evaluate the Safety and Tolerability of Oral Formulations of THC, Number of AEs during 14 days for healthy subjects and 20 days for post-chemotherapy patients vs active drug phase vs. Dronabinol active comparator

EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

Self-reported symptoms related to treatment. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the last days" EORTC QLQ-C30

LaSanta S A S

Immune System Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Multiple Sclerosis

Sclerosis

Neuralgia

Diabetes Mellitus

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Anti-Infective Agents

Central Nervous System Depressants

Antiemetics

Gastrointestinal Agents

Herbal and Botanical

Ethanol

Nabiximols

Peppermint oil

Peppermint

UK: All patients and who are prescribed Sativex®. Germany and Sweden: Patients who are prescribed Sativex® from selected specialist neurology centres.

Contains delta-9-tetrahydrocannabinol (THC), 27 mg/mL; cannabidiol (CBD), 25 mg/mL; in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.

Sativex®

The purpose of this registry is to monitor safety outcomes of patients who are receiving Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United Kingdom (UK), Germany and Sweden.

The objectives of this multi-centre, observational program are to evaluate the long-term safety of Sativex® with special regard to the following:

* The potential for addiction, abuse and misuse for illegal purposes
* The potential for long-term psychiatric effects including suicidality and psychosis
* The potential for mood changes / psychological effects (such as confusion / disorientation)
* The potential for memory impairment
* The effect on driving ability
* The potential for falls
* The use of MS concomitant medications

All physicians who are prescribing Sativex® in the UK and those from specialist neurology centres in Germany and Sweden will be invited to participate in the registry and will be provided with information regarding the background and objectives of the study. The prescribing physician will be asked to enter the following information via electronic Case Report Forms (CRF) at 6 monthly intervals for up to 24 months for any one patient:

Sativex® Use:

* Was Sativex® prescribed for Spasticity in MS? (Yes/No). If no, specify then indication for prescribing Sativex®
* Year of Spasticity diagnosis (Germany/Sweden only)
* Sativex® start date
* Sativex® daily dose (average, minimum and maximum)
* Date of last prescription
* Is Sativex® providing worthwhile benefit? (Yes/ No/ Don't Know)
* Has Sativex® been stopped permanently? (Yes /No). If yes, reason for stopping is to be provided.
* Sativex® stop date

Adverse Events (AE):

* Have any clinically significant adverse events been reported for this patient since they started taking Sativex® (initial record); did any clinically significant adverse events occur, or were ongoing, during this period (follow-up records) (If yes, the details are recorded on an AE form)
* Has the patient sought medical attention because of a fall related injury; since they started taking Sativex® (initial record); during this period (follow-up records) (If yes, the details are recorded on an AE form)
* Has the patient experienced any suicidal thoughts or attempted suicide; since they started taking Sativex® (initial record); during this period (follow-up records) (If yes, the details are recorded on an AE form)
* Has the patient experienced any other significant psychiatric or psychotic events; since they started taking Sativex® (initial record); during this period (follow-up records) (If yes, the details are recorded on an AE form)
* Has the patient reported any change in their driving ability; since they started taking Sativex® (initial record); during this period (follow-up records)

  * Improved
  * No change
  * Deteriorated
  * Not appropriate

Supporting Information:

* Medical History relevant to adverse events
* What other Spasticity medications have previously been used and are now stopped permanently (baclofen, tizanidine, benzodiazepines, gabapentin, botulinum toxin) (Germany/Sweden only)
* Changes to other MS symptom medications; since they started taking Sativex® (initial record); during this period (follow-up records)?

Survival status:

* Is the patient currently alive? If no, date of death and cause of death.
* Was the death due to suicide (Yes/No)

Paper CRF will also be available and will subsequently be entered into the electronic CRF database.

The data from the Registry will be analysed descriptively and collated into summary tables and listings.

A Registry report based upon the data summaries will be included within the Periodic Safety Update Reports for Sativex® and the results will be submitted to the appropriate Regulatory Agencies within 60 days of the data summaries tables and listings becoming available.

Each six monthly report and the data tables and listings will be reviewed by an independent Sativex® Registry Advisory Board and a summary overview will be prepared by the committee.

A final Registry report will be assembled within 180 days of the final study data being available.

Any significant safety issues identified will be communicated to the relevant Regulatory Agencies immediately.

An Observational Post-Marketing Safety Registry of Sativex®

An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®

The number of treatment-emergent adverse events was recorded. The incidence rate (number of patients divided by the total patient-years exposure to Sativex®) for each adverse event is presented.

The average daily dose of Sativex® was recorded and is presented.

Patients were asked if they had sought medical attention because of a fall-related injury; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

Patients were asked to report any change in their driving ability; since they started taking Sativex® (initial record); during this period (follow-up records). The markers were: Improved, No change, Deteriorated, Not appropriate. The number of patients for each marker is presented.

Patients were asked if they had experienced any suicidal thoughts or attempted suicide; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

Patients were asked if they had experienced any significant psychiatric or psychotic events other than suicidality; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

The incidence of treatment-emergent deaths was recorded and the number of patient deaths is presented.

Patients were asked if Sativex® was providing worthwhile benefit. The number of patients answering 'yes' at one or more time points is presented.

MS patients were asked what other anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.

MS patients were asked what medications for MS symptom other than anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Real World Evidence on the Use of Medical Cannabis in Pediatrics	NCT05863910	Cancer Epilepsy Neurodevelopmen...	Medical Cannabi...	3 Years - 17 Years	University of Manitoba
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
Real World Evidence on the Use of Medical Cannabis in Pediatrics	NCT05863910	Cancer Epilepsy Neurodevelopmen...	Medical Cannabi...	3 Years - 17 Years	University of Manitoba
CANnabinoids in Pediatric ONCology	NCT05754840	Childhood Cance... Cancer	MPL-001 MPL-005 MPL-009	4 Years - 18 Years	University of Manitoba
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC	NCT05272865	Nausea Post Che... Vomiting Cancer Pain Cancer Related ... Neoplasms	Pharmacokinetic...	18 Years -	LaSanta S A S
An Observational Post-Marketing Safety Registry of Sativex®	NCT02073474	Multiple Sclero... Diabetes Cancer Neuropathic Pai...	Sativex®	-	Jazz Pharmaceuticals

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