Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BX-1 · 1 trial · 1 indication
Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.
| Arm | Type | Description |
|---|---|---|
| BX-1 (dronabinol) | EXPERIMENTAL | BX-1 |
| Placebo | PLACEBO_COMPARATOR | Placebo of BX-1 |
| Name | Type | Description |
|---|---|---|
| BX-1 | DRUG | BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration. |
| Placebo | DRUG | Placebo of BX-1, oral solution |
Inclusion Criteria: 1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ≥ 26 2. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5 3. Men and women between 18 and 65 ye...