Adults 18 to 75, any sex, with Seizures. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Primary· From first dose of study drug up to Week 61
A TEAE was defined as an AE that started after the first dose of IMP in the open-label trial or a previously reported AE that increased in intensity, became serious, trial drug-related, or resulted in death, discontinuation, interruption, of reduction of IMP after the first dose of IMP in the open-label trial. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and requi
Participants with TEAE
Group
Value
95% CI
CVL-865 25 mg
88
Participants with TESAE
Group
Value
95% CI
CVL-865 25 mg
11
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)Primary· Baseline up to Week 57
12-lead ECGs recordings were obtained after the participant had been supine and at rest for at least 5 minutes. The number of participants with significant abnormalities is reported by 'change from baseline in QT interval as corrected for heart rate by Fridericia's formula (QTcF)'.
Group
Value
95% CI
CVL-865 25 mg
0
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign MeasurementsPrimary· Baseline up to Week 57
Vital signs were measured with the participant in a sitting/semi-recumbent position after 5 minutes rest and included temperature, systolic and diastolic blood pressure, and heart rate.
Group
Value
95% CI
CVL-865 25 mg
2
Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination ResultsPrimary· Baseline up to Week 57
A complete physical examination consisted of measurement of weight and a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart, lungs, lymph nodes, and gastrointestinal, genitourinary, and musculoskeletal systems. A full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength, and reflexes), sensation (including Romberg sign), coordination, and gait. Reported here is the number of participants with clinically significant chan
Number of participants with any clinically significant physical examination findings
Group
Value
95% CI
CVL-865 25 mg
5
Number of participants with any clinically significant neurological examination findings
Group
Value
95% CI
CVL-865 25 mg
7
Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)Primary· Baseline up to Week 61
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Suicidal Ideation: (1) Wish to be dead
Group
Value
95% CI
CVL-865 25 mg
6
Suicidal Ideation: (2) Non-specific active suicidal thoughts
Group
Value
95% CI
CVL-865 25 mg
5
Suicidal Ideation: (3) Active suicidal ideation with any methods (not plan) without intent to act
Group
Value
95% CI
CVL-865 25 mg
1
Suicidal Ideation: (4) Active suicidal ideation with some intent to act, without specific plan
Group
Value
95% CI
CVL-865 25 mg
2
Suicidal Ideation: (5) Active suicidal ideation with specific plan and intent
Group
Value
95% CI
CVL-865 25 mg
0
Change From End of Treatment in Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) Score at the End of Post-treatment Follow-up (Week 61)Primary· Week 57, Week 61
The modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) is a sensitive instrument to measure withdrawal under conditions where there is a taper of medication (rather than abrupt discontinuation). It consists of 17-items that monitor the type and severity of benzodiazepine withdrawal symptoms such as irritability, fatigue, appetite, and sleeplessness. The total score ranges from 1 (no withdrawal) to 68 (extreme withdrawal) with higher scores indicating more severe withdrawal.
Group
Value
95% CI
CVL-865 25 mg
-1.4
± 8.45
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 260 days..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04686786.