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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02954887 | Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) | PHASE3 | COMPLETED | 9 | — | — | May 12, 2017 | Jun 13, 2019 | Sep 2, 2022 | 7 | United States, Poland |
| NCT02953548 | Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) | PHASE3 | COMPLETED | 9 | — | — | Apr 24, 2017 | May 7, 2018 | Sep 2, 2022 | 8 | United States, Poland |
TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Clinical relevance was determined by the investigator.
Clinical significance was determined by the investigator.
Clinical significance was determined by the investigator.
Clinical significance was determined by the investigator.
Clinical relevance was determined by the investigator.
| Arm | Type | Description |
|---|---|---|
| GWP42003-P | EXPERIMENTAL | Administered orally, up to the target dose recommended by the data safety monitoring committee. Participants continue at the target dose, or the highest tolerated dose up to the target dose, for a total of 12 months' treatment. |
| Name | Type | Description |
|---|---|---|
| GWP42003-P | DRUG | Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. |
Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial. Key eligibility criteria for the blinded phase were as follows: Key Inclusion Criteria: * Participant is diagnosed with IS and has failed to respond a...