Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Nervous System Diseases

Cancer Pain

Pain

Marijuana Abuse

Neurologic Manifestations

Anticonvulsants

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Cannabidiol

Dronabinol

Nabiximols

Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both as extract of Cannabis sativa L.

Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.

Sativex

Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

GW-2000-02

Jeremy R Johnson, MB ChB

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

Subjects who have previously participated in GWCA0101, a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® (containing delta-9-tetrahydrocannabinol \[THC\] and cannabidiol \[CBD\]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.

Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.

The number of subjects who experienced an adverse event in this study is presented.

The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.

The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.

Jazz Pharmaceuticals

All AEs occurring during the study were reported on the running logs at the back of the study case report form.

Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD

Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC

THC Alone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Belgium

Region of Enrollment

Mr Richard Potts, Clinical Operations Director

Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)

All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.

The Incidence of Adverse Events as a Measure of Subject Safety

The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data

Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment

The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.

Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment

Overall Study

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Patients will received Sativex and Dose-Intense Temozolomide and in open-label manner

Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).

An open-label phase to assess the frequency and severity of adverse events in recurrent glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B). Part A will be reported here.

Patients will receive Sativex and dose-intense Temozolomide in an open-label phase. The incidence of adverse events will be monitored (Part A). An investigator led Safety Review Team will assess the safety profile of the open-label patients and decide whether the study can progress to the randomisation phase (Part B). Patients who enrol in the randomisation phase patients will receive either Sativex or placebo. The safety of Sativex compared to placebo will be assessed by pharmacokinetic analysis of Temozolomide and its metabolites, clinical laboratory tests, adverse events and vital signs.

A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

Adverse events will be coded according to the current medical dictionary for regular activities graded using the Common Terminology Criteria for Adverse Events criteria. The number of patients who experienced an adverse event whilst on treatment will be presented.

PFS6 will be assessment at Visit 11 (Day 190). Progression of disease will be determined from Response Assessment in Neuro-Oncology tumour assessment (based on Magnetic Resonance Imaging scans). The number of patients with PFS6 will be presented for the open-label phase (Part A).

Overall survival will be assessed at the end of the treatment visit (Day 358 or at early termination). The number of surviving patients from the open-label phase (Part A) will be presented.

Central Nervous System Depressants

Herbal and Botanical

Analgesics, Opioid

Peppermint

Sativex will be administered by trained, clinical trial personnel, via a pump action oromucosal spray. Sativex will be administered as 2 actuations (sprays) under the tongue or inside the cheeks every 4 minutes until 6 sprays have been administered. Following the administration of the first and second set of 2 actuations, patients will be offered 50 mL water to drink; and following the final set of 2 actuations, 100 mL of water will be offered (i.e., a total of 200 mL water will be offered during the Sativex dosing). There must be a period of at least 2 minutes and no more than 3 minutes between Sativex administration and consumption of water. Patients will not be permitted their regular medication until 2 hours post dose of investigational medicinal product (IMP) to minimize any possible drug interactions.

Sativex is supplied as a liquid containing 27 mg/mL Δ9-tetrahydrocannabinol (THC) and 25 mg/mL Cannabidiol (CBD) plus peppermint flavoring. Each 100 µL actuation of the pump-action spray delivers 100 µL 27 mg THC and 25 mg CBD.

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.

This is an open-label, multiple-centre, single dose clinical trial to assess the PK of a single oromucosal dose of Sativex in subjects with advanced cancer who are currently on background Step III opioid therapy.

A minimum of 25 subjects ≥18 years with advanced cancer will be needed for the assessment of the primary objective of the trial. The Screening Visit (Visit 1) will be performed within -10 to -2 days prior to dosing. For the Screening Visit, subjects will attend on an outpatient basis.

Subjects will be checked into the clinical research facility on Day -1 and will be confined to the clinical research facility for the Inpatient/Treatment Period (Day -1 to Day 3) (Visit 2). Subjects will be administered a single oromucosal dose of Sativex on Day 1 (time \[t\]=0). Fourteen PK blood samples will be taken from Day 1 to Day 3 during Visit 2: one predose sample and 13 postdose samples at the following time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours postdose.

Subjects will be discharged from the clinical research facility after the 48-hour PK blood sample has been taken and final safety assessments are completed. Subjects who discontinue from the trial prior to the completion of the PK blood draws will undergo the safety evaluations scheduled for Day 3.

The Safety Follow-up Call (Visit 3) will be made 7 (+2) days after dosing on Day 1. Subjects with any new adverse events (AEs) or clinical laboratory abnormalities will be asked to return for safety follow-up.

The expected duration for trial participation (including Screening Visit, Inpatient/Treatment Period, and Safety Follow-up Call) for each individual subject is a maximum of 19 days.

A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced Cancer

An Open-label, Multi-centre, Single-dose Clinical Trial to Assess the Pharmacokinetic (PK) Properties and Tolerability of a Single Oromucosal Dose of 6 Sprays of Sativex® in Patients With Advanced Cancer Currently on Background Step III Opioid Therapy

• Mean maximum plasma concentration (Cmax) of THC.

• Mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC(0-t)) of THC.

• Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞)) of THC.

• Mean time to maximum plasma concentration (tmax) of THC.

• Mean apparent clearance of drug from plasma after extravascular administration (CL/F) of THC.

• Mean apparent volume of distribution (Vd/F) of THC.

The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to follow-up visit.

The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented.

The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented.

The number of subjects with clinically significant changes in serum biochemistry, haematology and urinalysis, relative to the pre-treatment baseline, is presented.

The number of subjects with a clinically significant change in vital signs (supine/sitting blood pressure and pulse rate) indicative of an adverse event relative to the pre-treatment baseline, is presented.

Mouth and Tooth Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Stomatitis

Mucositis

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Anti-Infective Agents

Antiemetics

Gastrointestinal Agents

Ethanol

Peppermint oil

The PKs of a single dose of Sativex are investigated in subjects with mucositis of Radiation Therapy Oncology Group (RTOG) Grade 0 (i.e. at baseline, pre-induction of mucositis).

The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 1 (mild).

The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 2 (moderate).

The PKs of a single dose of Sativex are investigated in the same subjects when their mucositis is RTOG is Grade 3 (severe).

Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring.

Each vial contains 10 mL; each 100 uL actuation delivers 2.7 mg THC and 2.5 mg CBD.

James Ritter, DPhil FRCP FMedSci

To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics \[PKs\] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.

A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis

An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)

Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).

The numbers of subjects who experienced an adverse event during the study is presented.

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

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.

Spots Global Cancer Trial Database for sativex

Every month we try and update this database with for sativex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain	NCT00675948	Pain Cancer	Sativex GW-2000-02	18 Years -	Jazz Pharmaceuticals
A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma	NCT01812603	Cancer	Sativex	18 Years -	Jazz Pharmaceuticals
A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced Cancer	NCT02432612	Advanced Cancer	Sativex	18 Years -	Jazz Pharmaceuticals
A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis	NCT01975688	Head and Neck S...	Sativex	18 Years -	Jazz Pharmaceuticals
An Observational Post-Marketing Safety Registry of Sativex®	NCT02073474	Multiple Sclero... Diabetes Cancer Neuropathic Pai...	Sativex®	-	Jazz Pharmaceuticals
A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma	NCT01812603	Cancer	Sativex	18 Years -	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for sativex

Every month we try and update this database with for sativex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sativex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.