Approval Probability
TA Base Rate
Adjusted LOA
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Also known as CVL-865
CVL-865 High dose · 2 trials · 2 indications
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. |
| CVL-865 High dose | DRUG | High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day) |
| Alprazolam 1mg XR | DRUG | Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day) |
| CVL-865 low dose | DRUG | Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day) |
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 High dose refers to the higher-dose regimen of CVL-865, a small molecule being developed by AbbVie Inc. (ticker: ABBV). It is under study in psychiatry and neurology, specifically for panic disorder and seizures. The program remains in clinical development.
CVL-865 High dose is being studied for panic disorder and seizures. One completed Phase 1 trial evaluated its effect on panic symptoms induced by carbon dioxide inhalation in healthy subjects, while a completed Phase 2 trial tested it as adjunctive therapy for focal onset seizures.
CVL-865 High dose is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this higher-dose regimen of CVL-865 in panic disorder and seizure indications.
CVL-865 High dose is in Phase 1 development. It is investigational and has not been approved by the FDA. The program includes one completed Phase 1 trial in panic disorder and one completed Phase 2 trial in focal onset seizures.
CVL-865 High dose has been evaluated in two completed trials: NCT04592536, a Phase 1 study of its effect on carbon dioxide-induced panic symptoms in healthy subjects, and NCT04244175, a Phase 2 trial of adjunctive therapy for focal onset seizures that enrolled 154 participants across multiple countries.
Yes, CVL-865 High dose is the higher-dose regimen of CVL-865. The two names refer to the same investigational small molecule developed by AbbVie Inc. (ABBV), studied in panic disorder and seizures.