Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CVL-865 · 1 trial · 1 indication
Response Ratio (RRatio) is calculated as RRatio=(T-B)/(T+B) ×100, where T represents the focal onset seizure frequency rate per week in the Maintenance Phase and B represents the focal onset seizure frequency rate per week in the Baseline Period. The Response Ratio ranges between -100 and 100; negative values indicate reduction in seizure rate and positive values indicate increase in seizure rate during treatment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received a placebo matched to CVL-865 tablets orally twice a day (BID) during the 2-week Titration Phase, the 8-week Maintenance Phase, and the 3-week Taper Phase. |
| CVL-865 7.5 mg BID | EXPERIMENTAL | CVL-865 tablets were administered orally as 2.5 mg twice a day (BID) for 1 week followed by 5 mg BID for another week during the Titration Phase, and then 7.5 mg BID during the 8-week Maintenance Phase. For participants not enrolling into the open-label extension trial, following the Maintenance Phase the dose was gradually decreased over a 3-week Taper Phase. |
| CVL-865 25 mg BID | EXPERIMENTAL | CVL-865 tablets were administered orally as 5 mg twice a day (BID) for 1 week followed by 12.5 mg for another week during the Titration Phase, and then 25 mg BID during the 8-week Maintenance Phase. For participants not enrolling into the open-label extension trial, following the Maintenance Phase the dose was gradually decreased over a 3-week Taper Phase. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants received CVL-865 matched placebo tablets orally twice a day (BID) during the Treatment Period. |
| CVL-865 | DRUG | Participants received CVL-865 tablets orally twice a day (BID) up to the maximum dose of 7.5 mg BID or 25 mg BID during the Treatment Period. |
Inclusion Criteria: * Participants with a diagnosis of epilepsy with focal onset, as defined in the International League Against Epilepsy (ILAE) Classification of Seizures, focal aware (except participants with only focal aware seizures without a motor component), focal impaired awareness, and foca...
CVL-865 is an investigational small molecule being developed for the treatment of seizures. It is being studied as an adjunctive therapy in patients with focal onset seizures. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
CVL-865 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of CVL-865 as an adjunctive treatment for focal onset seizures.
CVL-865 is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the drug as adjunctive therapy for focal onset seizures. The drug is investigational and has not received FDA approval. Its safety and efficacy have not been established.
CVL-865 has one completed Phase 2 clinical trial, registered as NCT04244175. This randomized, double-blind, placebo-controlled study enrolled 154 participants aged 18 years and older with seizures. The trial was conducted across multiple countries, including the United States, Australia, Poland, Serbia, South Korea, Spain, and Ukraine.
CVL-865 is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound. It is being studied under the name CVL-865 in clinical trials for the treatment of focal onset seizures.