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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03802799 | Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS | PHASE2 | ACTIVE NOT_RECRUITING | 476 | — | — | Nov 9, 2018 | Jun 30, 2026 | May 27, 2026 | 26 | United States, Australia +2 |
| NCT03614663 | Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX) | PHASE2 | COMPLETED | 212 | — | — | Jun 12, 2018 | Jun 14, 2020 | Jul 6, 2022 | 21 | United States, Australia +1 |
Safety assessment will include collection of any treatment emergent adverse events
The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 12, and a higher value indicates a worse outcome.
The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 12, and the higher score means a worse outcome.
| Arm | Type | Description |
|---|---|---|
| ZYN002 | EXPERIMENTAL | ZYN002 - cannabidiol Transdermal Gel |
| ZYN002 - Cannabidiol transdermal gel | EXPERIMENTAL | ZYN002 supplied as a transdermal gel. Patients weighing less than or equal to 35 kg will be randomized to receive either 125 mg cannabidiol Q12H or placebo. Patients weighing greater than 35 kg will be randomized to receive 250 mg cannabidiol Q12H or placebo. |
| Placebo transdermal gel | PLACEBO_COMPARATOR | Matching ZYN002 placebo supplied as a transdermal gel. |
| Name | Type | Description |
|---|---|---|
| ZYN002 - Cannabidiol Transdermal Gel | DRUG | Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery) |
| Placebo Transdermal Gel | OTHER | Placebo formulated as a clear gel (transdermal delivery) |
Inclusion Criteria: * Participated in study ZYN2-CL-016 or Study ZYN2-CL-033. * Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures. * Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give wr...