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A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-01-10
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
This was a multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of GW-1000-02 in central neuropathic pain associated with spinal cord injury. Patients were screened to determine eligibility and completed a seven to 21 day baseline period. Patients then returned to the centre for assessment, randomisation and initial dosing. Visits occurred at the end of treatment week one and at the end of the study (treatment week three) or upon withdrawal. Throughout the study, patients were permitted to take paracetamol as escape analgesic to relieve breakthrough pain. Patients in this study could elect to be screened for an open label extension study of GW-1000-02.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
SativexContained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 55 | -0.74 | 1.12 |
| Placebo | 59 | -0.69 | 1.39 |
Eligibility
primary outcomes
Time frame: Up to 51 days
The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.
secondary outcomes
Time frame: Up to 51 days
The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.
Time frame: Up to 51 days
Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Time frame: Up to 51 days
Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Time frame: 0 - 51 days
Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.
Time frame: Up to 51 days
Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.
Publications
No exact PMID-linked public article is currently readable locally.
The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 55 | -4.68 | 18.25 |
| Placebo | 59 | -2.91 | 20.83 |
Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 42 | -0.50 | 1.46 |
| Placebo | 48 | -0.69 | 1.59 |
Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 52 | -1.92 | 20.01 |
| Placebo | 59 | -1.57 | 22.62 |
Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 35 | -0.37 | 1.25 |
| Placebo | 43 | -0.46 | 1.80 |
Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 50 | 0.86 | 6.71 |
| Placebo | 59 | 0.48 | 14.76 |
The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 40 | -0.13 | 0.43 |
| Placebo | 44 | -0.01 | 0.42 |
Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function . A negative value from baseline indicates a deterioration.
Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 55 | 0.4 | 2.79 |
| Placebo | 58 | 0.2 | 2.98 |
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.
Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 55 | 0.1 | 1.41 |
| Placebo | 58 | 0.1 | 1.30 |
Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.
Population: All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 12 | -0.3 | 2.73 |
| Placebo | 16 | 1.2 | 3.45 |
The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.
Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 56 | 30 | - |
| Placebo | 60 | 12 | - |
The Brief Pain Inventory is a 14-item questionnaire that asks patients 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 is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 53 | -3.1 | 5.22 |
| Placebo | 57 | -1.2 | 4.64 |
Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.
Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 55 | -0.41 | 0.59 |
| Placebo | 59 | -0.38 | 0.73 |
The number of patients who experienced an adverse event during the study is presented.
Population: All randomised patients who received at least one dose of study drug were included in the Safety population.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 56 | 46 | - |
| Placebo | 60 | 29 | - |
| Milestone | GW-1000-02 | Placebo |
|---|---|---|
| STARTED | 56 | 60 |
| COMPLETED | 49 | 57 |
| NOT COMPLETED | 7 | 3 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Anaemia Not Otherwise Specified Aggravated | Blood and lymphatic system disorders | GW-1000-02: 1 / 56 · Placebo: 0 / 60 |
| Fall | General disorders | GW-1000-02: 1 / 56 · Placebo: 1 / 60 |
| Methicillin-resistant Staphylococcus aureus infection | Infections and infestations | GW-1000-02: 1 / 56 · Placebo: 0 / 60 |
| Bladder Infection Not Otherwise Specified | Infections and infestations | GW-1000-02: 0 / 56 · Placebo: 1 / 60 |
| Pneumonia Not Otherwise Specified | Infections and infestations | GW-1000-02: 0 / 56 · Placebo: 1 / 60 |
| Tibia Fracture | Injury, poisoning and procedural complications | GW-1000-02: 1 / 56 · Placebo: 0 / 60 |
| Upper Limb Fracture Not Otherwise Specified | Injury, poisoning and procedural complications | GW-1000-02: 0 / 56 · Placebo: 1 / 60 |
| Dizziness | Nervous system disorders | GW-1000-02: 0 / 56 · Placebo: 1 / 60 |
| Confusion | Psychiatric disorders | GW-1000-02: 1 / 56 · Placebo: 0 / 60 |
| Paranoia | Psychiatric disorders | GW-1000-02: 1 / 56 · Placebo: 0 / 60 |
| Contusion | Skin and subcutaneous tissue disorders | GW-1000-02: 0 / 56 · Placebo: 1 / 60 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea | Gastrointestinal disorders | GW-1000-02: 6 / 56 · Placebo: 3 / 60 |
| Constipation | Gastrointestinal disorders | GW-1000-02: 4 / 56 · Placebo: 0 / 60 |
| Dry Mouth | Gastrointestinal disorders | GW-1000-02: 4 / 56 · Placebo: 0 / 60 |
| Oral Pain | Gastrointestinal disorders | GW-1000-02: 2 / 56 · Placebo: 3 / 60 |
| Lethargy | General disorders | GW-1000-02: 4 / 56 · Placebo: 0 / 60 |
| Feeling Abnormal | General disorders | GW-1000-02: 3 / 56 · Placebo: 0 / 60 |
| Feeling Drunk | General disorders | GW-1000-02: 3 / 56 · Placebo: 0 / 60 |
| Urinary Tract Infection Not Otherwise Specified | Infections and infestations | GW-1000-02: 8 / 56 · Placebo: 4 / 60 |
| Alanine Aminotransferase Increased | Investigations | GW-1000-02: 2 / 56 · Placebo: 3 / 60 |
| Gamma-Glutamyltransferase Increased | Investigations | GW-1000-02: 2 / 56 · Placebo: 3 / 60 |
| Dizziness | Nervous system disorders | GW-1000-02: 14 / 56 · Placebo: 5 / 60 |
| Dysgeusia | Nervous system disorders | GW-1000-02: 9 / 56 · Placebo: 4 / 60 |
| Somnolence | Nervous system disorders | GW-1000-02: 7 / 56 · Placebo: 0 / 60 |
| Headache Not Otherwise Specified | Nervous system disorders | GW-1000-02: 5 / 56 · Placebo: 0 / 60 |
| Disturbance in Attention | Nervous system disorders | GW-1000-02: 3 / 56 · Placebo: 0 / 60 |
| Vision Blurred | Eye disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Oral Discomfort | Gastrointestinal disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Vomiting Not Otherwise Specified | Gastrointestinal disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Application Site Pain | General disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Fatigue | General disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Pain Exacerbated | General disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Fall | General disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Feeling of Relaxation | General disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Pyrexia | General disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Blood Bilirubin Increased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Blood Sodium Decreased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Haematocrit Decreased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Haemoglobin Decreased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Red Blood Cell Count Decreased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| White Blood Cell Count Increased | Investigations | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Neutrophil Count Increased | Investigations | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Speech Disorder | Nervous system disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Paraesthesia | Nervous system disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Confusion | Psychiatric disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
| Insomnia | Psychiatric disorders | GW-1000-02: 0 / 56 · Placebo: 2 / 60 |
| Flushing | Vascular disorders | GW-1000-02: 2 / 56 · Placebo: 0 / 60 |
Time frame: Up to 51 days
The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.
Time frame: Up to 51 days
Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function . A negative value from baseline indicates a deterioration.
Time frame: Up to 51 days
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.
Time frame: Up to 51 days
Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.
Time frame: Up to 51 days
The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.
Time frame: 0 - 51 days
The Brief Pain Inventory is a 14-item questionnaire that asks patients 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 is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.
Time frame: 0 - 51 days
Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.
Time frame: Up to 61 days
The number of patients who experienced an adverse event during the study is presented.