Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01606137 | A Study of the Long-term Safety of Sativex Use | PHASE3 | COMPLETED | 507 | — | — | Feb 1, 2002 | Dec 1, 2004 | May 6, 2023 | 1 | United Kingdom |
| NCT01610687 | A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | PHASE3 | COMPLETED | 137 | — | — | Jul 1, 2001 | Feb 1, 2005 | Jan 10, 2023 | 1 | United Kingdom |
| NCT01610700 | An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients | PHASE3 | COMPLETED | 160 | — | — | May 1, 2001 | Jul 1, 2002 | Jan 12, 2023 | 1 | United Kingdom |
| NCT01610713 | An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | PHASE3 | COMPLETED | 154 | — | — | May 1, 2001 | Jul 1, 2002 | Jan 10, 2023 | 1 | United Kingdom |
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.
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 | Control |
| Name | Type | Description |
|---|---|---|
| GW-1000-02 | DRUG | Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and 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 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation. |
| Placebo | DRUG | Each actuation of placebo delivered the excipients only. |
Inclusion Criteria: * Willing and able to give informed consent. * Male or female aged 18 years or above. * Diagnosed with a condition categorised as one of the following: multiple sclerosis, spinal cord conditions, peripheral nerve injury or central nervous system damage associated with vascular, ...