Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW-1000-02 · 7 trials · 3 indications
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.
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
The number of patients who experienced an adverse event during the course of this extension study is presented
This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.
This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.
| Arm | Type | Description |
|---|---|---|
| GW-1000-02 | EXPERIMENTAL | Active treatment. |
| Placebo | PLACEBO_COMPARATOR | Placebo control. |
| GW-2000-02 | EXPERIMENTAL | Active treatment. |
| Name | Type | Description |
|---|---|---|
| GW-1000-02 | DRUG | 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. |
| Placebo | DRUG | Contained 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. |
| GW-2000-02 | DRUG | Contains THC (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 2.5 mg). The maximum daily exposure was set at 48 actuations per day. |
Inclusion Criteria: * Gave informed consent for participation in the study. * Male or Female, aged 18 years or above. * Diagnosis of non-acute spinal cord injury, with central neuropathic pain not wholly relieved by current therapy. * Central neuropathic pain with a mean severity Numerical Rating S...
GW-1000-02 is an investigational small molecule being developed for multiple sclerosis and pain. It is being studied in Phase 3 clinical trials for these neurological conditions. The drug is not yet approved and remains in clinical development.
GW-1000-02 is being developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is conducting Phase 3 clinical trials to evaluate the drug for multiple sclerosis and pain.
GW-1000-02 is in Phase 3 clinical development. It is being studied for multiple sclerosis and pain, but it is not yet approved. The drug is investigational and still undergoing clinical trials to assess its safety and efficacy.
GW-1000-02 has completed four Phase 3 clinical trials. These include NCT01606176 for pain of neurological origin, NCT01606189 for brachial plexus injury pain, NCT01606202 for spinal cord injury pain, and NCT01610687, a long-term safety extension study in multiple sclerosis.
GW-1000-02 is a cannabis based medicine. Clinical trials describe it as a sublingual cannabis based medicine extract containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). It is being studied for multiple sclerosis and pain.