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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05126888 | SCI-110 in the Treatment of Tourette Syndrome | PHASE2 | NOT YET_RECRUITING | 164 | — | — | Jun 1, 2026 | Feb 1, 2028 | Apr 21, 2026 | 3 | United States, Germany +1 |
Absolute change from baseline in revised version of YGTSS-R-TTS as a continuous endpoint at week 12 of the respective treatment period. The Global Severity Score has a range of 0- 100. A higher score on the scale suggests a more severe Tic, or a greater impact the Tic has on the person's life.
| Arm | Type | Description |
|---|---|---|
| SCI-110 | EXPERIMENTAL | Cannabinoid-based medication consisting of Dronabinol and PEA |
| Dronabinol | PLACEBO_COMPARATOR | Placebo matched in taste, odour and appearance to SCI-110 |
| Name | Type | Description |
|---|---|---|
| SCI-110 | DRUG | SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day. |
| Placebo | OTHER | Pill that matches in taste, odour and appearance to SCI-110 active pills |
Inclusion Criteria: 1. Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 2. Male and female subjects with an age between ≥18 and ≤65 years 3. Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14 4. Clinical Glo...