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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02365610 | A Study of GWP42006 in People With Focal Seizures - Part B | PHASE2 | COMPLETED | 162 | — | — | Mar 1, 2016 | Sep 1, 2017 | Dec 20, 2022 | 26 | Czechia, Hungary +4 |
| NCT02369471 | A Study of GWP42006 in People With Focal Seizures - Part A | PHASE2 | COMPLETED | 32 | — | — | Mar 1, 2015 | Nov 1, 2015 | Dec 20, 2022 | 9 | Czechia, Spain +1 |
| NCT01918735 | A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects | PHASE1 | COMPLETED | 66 | — | — | Aug 1, 2013 | Dec 1, 2013 | Dec 20, 2022 | 1 | United Kingdom |
The number of subjects who experienced an adverse event during each arm of the study is presented.
| Arm | Type | Description |
|---|---|---|
| GWP42006 | EXPERIMENTAL | GWP42006 |
| Placebo control | PLACEBO_COMPARATOR | Placebo |
| Group 1a | EXPERIMENTAL | Subjects on inducer AEDs will administer GWP42006. |
| Group 2a | ACTIVE_COMPARATOR | Subjects on inhibitor AEDs will administer GWP42006. |
| Group 3a | EXPERIMENTAL | Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006. |
| Group 1b | PLACEBO_COMPARATOR | Matching placebo control for Group 1a. |
| Group 2b | PLACEBO_COMPARATOR | Matching placebo control for Group 2a. |
| Group 3b | PLACEBO_COMPARATOR | Matching placebo control for Group 3a. |
| Group/dose level 1a | EXPERIMENTAL | 25 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 1b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 1a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2a | EXPERIMENTAL | 75 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 2a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 3a | EXPERIMENTAL | 200 mg GWP42006 oral solution (single dose) followed by an intravenous administration of 5 mg GWP42006 after the oral dose |
| Group/dose level 3b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 3a |
| Group/dose level 4a | EXPERIMENTAL | 400 mg GWP42006 oral solution |
| Group/dose level 4b | PLACEBO_COMPARATOR | Matching placebo for Group/dose level 4a |
| GWP42006 1, 2, or 3 times daily | EXPERIMENTAL | Subjects will receive the selected dose of GWP42006 once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
| Placebo 1, 2, or 3 times daily | PLACEBO_COMPARATOR | Subjects will receive placebo once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
| Name | Type | Description |
|---|---|---|
| GWP42006 | DRUG | - |
| Placebo Control | DRUG | - |
| Placebo | DRUG | - |
For inclusion in Part B of the study patients must fulfil ALL of the following criteria: * Male or female aged between 18 and 65 years, inclusive. * Well-documented history of focal epilepsy, compatible electroencephalogram and clinical history. * Documented computerized tomography / magnetic reson...