A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
Summary
The goal of this clinical trial is to learn if CVL-865, when taken regularly with other anti-seizure medicines, works to prevent seizures in adults with drug-resistant focal onset seizures. It will also learn about the safety of CVL-865. The main question it aims to answer is whether CVL-865, when taken regularly with other anti-seizure medicines, lowers the number of seizures in those with a diagnosis of epilepsy with drug-resistant focal onset seizures. This study has an 8-week Screening/Baseline Period, a 13-week Treatment Period (including a 2-week Titration Phase, an 8-week Maintenance Phase, and a 3-week Taper Phase), and a 4-week Safety Follow-Up Period. Participants will take CVL-865 or a placebo twice a day during the 10-13 week Treatment Period, visit the clinic every few weeks for checkups, tests, and surveys, and fill out an e-Diary.
Timeline
- Start
- 2020-01-27
- Primary completion
- 2024-05-21
- Completion
- 2024-05-21
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs CVL-865 25 mg BID; p =0.986; LS Mean Difference 0.11 (90% CI -10.38 to 10.61); ANCOVA NCT04244175 ↗
registry analysis (superiority test); Placebo vs CVL-865 7.5 mg BID; p =0.823; LS Mean Difference 1.42 (90% CI -9.04 to 11.87); ANCOVA NCT04244175 ↗
registry analysis (superiority test); Placebo vs CVL-865 7.5 mg BID / 25 mg BID; p =0.888; LS Mean Difference 0.76 (90% CI -8.23 to 9.76); ANCOVA NCT04244175 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darigabat | Small molecule | 7.5 mg | — |
| Subject | Darigabat | Small molecule | 25 mg | — |