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The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-05-03
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 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. The study provided continued availability of Sativex® to subjects who completed the preceding double-blind neuropathic pain studies. Consenting, eligible subjects who had participated in previous GW Pharma Ltd (GW) randomised, placebo-controlled clinical studies entered the study (Visit 1, Day 0) and commenced dosing. Study visits took place at Week 2 (Visit 2, Day 14), Week 14 (Visit 3, Day 98), and Week 26 (Visit 4, Day 182). Subjects returned to the centre for an end of treatment visit at week 38 (Visit 5, Day 266). All subjects received Sativex®. This was followed by a five week randomised-withdrawal phase (Part B) for a subset of subjects. An end of study visit took place 28 days after Visit 5 (or 5b or 5c) or withdrawal from the study.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
GW-1000-02Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 365 | -2.07 | 2.13 |
The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
Eligibility
primary outcomes
Time frame: 38 weeks
The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.
secondary outcomes
Time frame: 38 weeks
The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Time frame: 38 weeks
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time frame: week 38
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time frame: 38 weeks
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Publications
No exact PMID-linked public article is currently readable locally.
| Group | N | Value | Spread / interval |
|---|
| Sativex | 371 | -15.67 | 19.11 |
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 374 | -1.76 | 2.93 |
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 380 | 41 | - |
| Sativex | 380 | 107 | - |
| Sativex | 380 | 99 | - |
| Sativex | 380 | 79 | - |
| Sativex | 380 | 14 | - |
| Sativex | 380 | 12 | - |
| Sativex | 380 | 4 | - |
| Sativex | 380 | 24 | - |
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 380 | 0.07 | 0.208 |
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 380 | 6.27 | 23.35 |
The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 380 | 295 | - |
The patient was asked "on a scale of '0 to 10' please indicate the average level of your intoxication due to medications over the last 24 hours" (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline.
Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 356 | 0.6 | 2.62 |
| Milestone | Sativex |
|---|---|
| STARTED | 380 |
| COMPLETED | 234 |
| NOT COMPLETED | 146 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| IDIOPATHIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | Sativex: 1 / 380 |
| ANGINA PECTORIS | Cardiac disorders | Sativex: 2 / 380 |
| LEFT VENTRICULAR FAILURE | Cardiac disorders | Sativex: 1 / 380 |
| MYOCARDIAL INFARCTION | Cardiac disorders | Sativex: 1 / 380 |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | Sativex: 1 / 380 |
| DIARRHOEA | Gastrointestinal disorders | Sativex: 1 / 380 |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | Sativex: 1 / 380 |
| HAEMATEMESIS | Gastrointestinal disorders | Sativex: 1 / 380 |
| INTESTINAL FUNCTIONAL DISORDER | Gastrointestinal disorders | Sativex: 1 / 380 |
| OESOPHAGEAL DISCOMFORT | Gastrointestinal disorders | Sativex: 1 / 380 |
| PANCREATITIS ACUTE | Gastrointestinal disorders | Sativex: 1 / 380 |
| VOMITING | Gastrointestinal disorders | Sativex: 1 / 380 |
| CHEST PAIN | General disorders | Sativex: 2 / 380 |
| OEDEMA PERIPHERAL | General disorders | Sativex: 2 / 380 |
| PYREXIA | General disorders | Sativex: 1 / 380 |
| CELLULITIS | Infections and infestations | Sativex: 2 / 380 |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | Sativex: 2 / 380 |
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | Sativex: 1 / 380 |
| LOCALISED INFECTION | Infections and infestations | Sativex: 1 / 380 |
| ORAL FUNGAL INFECTION | Infections and infestations | Sativex: 1 / 380 |
| PNEUMONIA | Infections and infestations | Sativex: 1 / 380 |
| HEPATIC ENZYME INCREASED | Investigations | Sativex: 1 / 380 |
| DEHYDRATION | Metabolism and nutrition disorders | Sativex: 1 / 380 |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | Sativex: 1 / 380 |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Sativex: 1 / 380 |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | Sativex: 2 / 380 |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | Sativex: 1 / 380 |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | Sativex: 1 / 380 |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Sativex: 1 / 380 |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| COLON CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| NEURILEMMOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 380 |
| AMNESIA | Nervous system disorders | Sativex: 2 / 380 |
| CAROTID ARTERY OCCLUSION | Nervous system disorders | Sativex: 1 / 380 |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | Sativex: 1 / 380 |
| CERVICAL ROOT PAIN | Nervous system disorders | Sativex: 1 / 380 |
| DIABETIC COMA | Nervous system disorders | Sativex: 1 / 380 |
| FACIAL PARESIS | Nervous system disorders | Sativex: 1 / 380 |
| HEADACHE | Nervous system disorders | Sativex: 1 / 380 |
| PARAPLEGIA | Nervous system disorders | Sativex: 1 / 380 |
| SOMNOLENCE | Nervous system disorders | Sativex: 1 / 380 |
| SPINAL CORD INFARCTION | Nervous system disorders | Sativex: 1 / 380 |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | Sativex: 1 / 380 |
| DISORIENTATION | Psychiatric disorders | Sativex: 1 / 380 |
| PARANOIA | Psychiatric disorders | Sativex: 1 / 380 |
| SUICIDE ATTEMPT | Psychiatric disorders | Sativex: 1 / 380 |
| RENAL FAILURE ACUTE | Renal and urinary disorders | Sativex: 1 / 380 |
| PELVIC PAIN | Reproductive system and breast disorders | Sativex: 1 / 380 |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Sativex: 2 / 380 |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Sativex: 1 / 380 |
| DEEP VEIN THROMBOSIS | Vascular disorders | Sativex: 2 / 380 |
| HYPERTENSION | Vascular disorders | Sativex: 1 / 380 |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | Sativex: 1 / 380 |
| THROMBOPHLEBITIS | Vascular disorders | Sativex: 1 / 380 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dizziness | Nervous system disorders | Sativex: 79 / 380 |
| Dysgeusia | Nervous system disorders | Sativex: 29 / 380 |
| Somnolence | Nervous system disorders | Sativex: 28 / 380 |
| Headache | Nervous system disorders | Sativex: 23 / 380 |
| Balance Disorder | Nervous system disorders | Sativex: 12 / 380 |
| Memory Impairment | Nervous system disorders | Sativex: 12 / 380 |
| Nausea | Gastrointestinal disorders | Sativex: 42 / 380 |
| Dry Mouth | Gastrointestinal disorders | Sativex: 30 / 380 |
| Vomiting | Gastrointestinal disorders | Sativex: 25 / 380 |
| Diarrhoea | Gastrointestinal disorders | Sativex: 17 / 380 |
| Mouth Ulceration | Gastrointestinal disorders | Sativex: 16 / 380 |
| Fatigue | General disorders | Sativex: 31 / 380 |
| Feeling Drunk | General disorders | Sativex: 21 / 380 |
| Nasopharyngitis | Infections and infestations | Sativex: 15 / 380 |
| Urinary Tract Infection | Infections and infestations | Sativex: 13 / 380 |
| Disorientation | Psychiatric disorders | Sativex: 19 / 380 |
| Depressed Mood | Psychiatric disorders | Sativex: 13 / 380 |
| Insomnia | Psychiatric disorders | Sativex: 13 / 380 |
| Depression | Psychiatric disorders | Sativex: 12 / 380 |
| Dissociation | Psychiatric disorders | Sativex: 10 / 380 |
| Back Pain | Musculoskeletal and connective tissue disorders | Sativex: 11 / 380 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | Sativex: 11 / 380 |
| Cough | Respiratory, thoracic and mediastinal disorders | Sativex: 14 / 380 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Sativex: 11 / 380 |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
Time frame: 38 weeks
The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Time frame: 42 weeks
The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).
Time frame: 38 weeks
The patient was asked "on a scale of '0 to 10' please indicate the average level of your intoxication due to medications over the last 24 hours" (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline.
| Sativex: 10 / 380 |
| Hypoglycaemia | Metabolism and nutrition disorders | Sativex: 12 / 380 |
| Accident | Injury, poisoning and procedural complications | Sativex: 11 / 380 |
| Hypertension | Vascular disorders | Sativex: 10 / 380 |
| Vertigo | Ear and labyrinth disorders | Sativex: 14 / 380 |
| Lower Respiratory Tract Infection | Infections and infestations | Sativex: 17 / 380 |