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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05085561 | The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 | PHASE2 | COMPLETED | 62 | — | — | Mar 17, 2022 | Jun 30, 2025 | Aug 6, 2025 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| REC-994 200 mg | ACTIVE_COMPARATOR | REC-994 200 mg po once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet) |
| REC-994 400 mg | ACTIVE_COMPARATOR | REC-994 400 mg po QD (2 200 mg REC-994 tablets) |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo po QD (2 matching placebo tablets) |
| Name | Type | Description |
|---|---|---|
| REC-994 | DRUG | REC-994 200 mg tablets |
| Placebo | DRUG | Placebo Tablets |
Inclusion criteria: 1. 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI 2. Have symptomatic CCM 3. Have provided written informed consent to participate in the study 4. Have not participated in a clinical trial utilizing an investigational agent within 28 days or within ...