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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04977986 | Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome | PHASE3 | COMPLETED | 215 | — | — | Sep 13, 2021 | Aug 29, 2025 | Dec 17, 2025 | 27 | United States, Australia +3 |
The ABC-C FXS is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials
| Arm | Type | Description |
|---|---|---|
| ZYN002 - transdermal gel | EXPERIMENTAL | Pharmaceutically manufactured. Cannabidiol is formulated as a clear gel for transdermal delivery. |
| Placebo transdermal gel | PLACEBO_COMPARATOR | Placebo is formulated as a clear gel for transdermal delivery. |
| Name | Type | Description |
|---|---|---|
| ZYN002 - transdermal gel | DRUG | Pharmaceutically manufactured cannabidiol formulated as a clear gel that can be applied to the skin (transdermal delivery) |
| Placebo | DRUG | Placebo formulated as a clear gel that can be applied to the skin (transdermal delivery) Other Names: Placebo Comparator Matching Placebo |
Inclusion Criteria: * Male or female children and adolescents aged 3 to \< 30 years, at the time of Screening. * Patient resides with caregiver who will continue to provide consistent care throughout the study. * Judged by the Investigator to be in generally good health at Screening based upon the ...