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An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.
Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW-1000-02 | Experimental | Active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW-1000-02 | Drug | Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events as a Measure of Patient Safety | The number of patients who experienced an adverse event during the course of this extension study is presented | up to1206 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment | A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation. | up to 1206 days |
| Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rivermead Rehabilitation Centre | Oxford | OX3 7LD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17086911 | Result | Wade DT, Makela PM, House H, Bateman C, Robson P. Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Mult Scler. 2006 Oct;12(5):639-45. doi: 10.1177/1352458505070618. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GW-1000-02 | GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 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:CBD 120 mg) in 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GW-1000-02 | Active treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events as a Measure of Patient Safety | The number of patients who experienced an adverse event during the course of this extension study is presented | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Number | participants | up to1206 days |
|
All adverse events occurring from during the extension study (up to 1049 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GW-1000-02 | Contains THC (27 mg/ml) and CBD (25 mg/ml). 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection Not Otherwise Specified (NOS) | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharma Ltd. | 0044 1223 266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
|
Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels. |
| 18 weeks |
| Investigator Assessed Global Severity Score at Week 18 | The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented. | week 18 |
| Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement. | week 18 |
| Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement. | week 18 |
| Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement. | week 18 |
| Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement. | 18 weeks |
| Withdrawal by Subject |
|
| Lost to Follow-up |
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| Symptom control without study medication |
|
| Unable to make journey |
|
| Death |
|
| Cannabis affecting job |
|
| Felt more alter without study medication |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment | A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | sprays of study medication | up to 1206 days |
|
|
|
| Secondary | Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18. | Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | units on a scale | 18 weeks |
|
|
|
| Secondary | Investigator Assessed Global Severity Score at Week 18 | The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Number | participants | week 18 |
|
|
|
| Secondary | Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | units on a scale | week 18 |
|
|
|
| Secondary | Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | units on a scale | week 18 |
|
|
|
| Secondary | Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | units on a scale | week 18 |
|
|
|
| Secondary | Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18 | A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement. | All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population. | Posted | Mean | Standard Deviation | units on a scale | 18 weeks |
|
|
|
| 23 |
| 137 |
| 127 |
| 137 |
| Pneumonia NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Bone infection NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Balance Impaired NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Convulsions NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Weakness | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 5.0 | Systematic Assessment |
|
| Lower Limb Fracture NOS | Injury, poisoning and procedural complications | MedDRA 5.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Muscle Weakness NOS | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5.0 | Systematic Assessment |
|
| Breast Cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5.0 | Systematic Assessment |
|
| Lung Cancer Stage Unspecified (excl metastatic tumours to lung) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5.0 | Systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 5.0 | Systematic Assessment |
|
| Biliary Cirrhosis Primary | Hepatobiliary disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Psychotic Disorder NOS | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Deep Vein Thrombosis NOS | Vascular disorders | MedDRA 5.0 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 5.0 | Systematic Assessment |
|
| Hyperglycaemia NOS | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| DIARRHOEA NOS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| VOMITING NOS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| GLOSSODYNIA | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| ORAL MUCOSAL DISORDER | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| ORAL DISCOMFORT | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| LOOSE STOOLS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| TOOTH DISCOLOURATION | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| FALL | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| WEAKNESS | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| LETHARGY | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| APPLICATION SITE IRRITATION | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| APPLICATION SITE PAIN | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| FEELING ABNORMAL | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| TOOTH CARIES NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| BACTERIAL INFECTION NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| BLADDER INFECTION NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| VAGINAL CANDIDIASIS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| VIRAL INFECTION NOS | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
|
| PAIN IN LIMB | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| MUSCLE WEAKNESS NOS | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| PERIPHERAL SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| HEADACHE NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| BALANCE IMPAIRED NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS AGGRAVATED | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| SHORT-TERM MEMORY LOSS | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| CONTUSION | Skin and subcutaneous tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |