NCT04244175 is a Phase 2 clinical trial of CVL-865 in Seizures, sponsored by AbbVie.

Who is sponsoring NCT04244175?

NCT04244175 is sponsored by AbbVie.

What drugs are being tested in NCT04244175?

Interventions in NCT04244175: Placebo, CVL-865.

Is NCT04244175 still recruiting?

NCT04244175 is currently completed. Last updated 30 May 2025.

Are results published for NCT04244175?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-30 · How we verify

NCT04244175

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

Completed Phase 2 Results posted Last updated 30 May 2025

What this trial tests

Phase 2 trial testing Placebo in Seizures in 154 participants. Completed in 21 May 2024.

Timeline

27 January 2020

Primary endpoint
21 May 2024

21 May 2024

Quick facts

Lead sponsor	AbbVie
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	154
Start date	27 January 2020
Primary completion	21 May 2024
Estimated completion	21 May 2024
Sites	76 locations across Ukraine, Serbia, Poland, South Korea, Australia, United States, Spain

Drugs / interventions tested

Placebo
CVL-865 — full drug profile →

Conditions studied

Seizures — all drugs for Seizures →

Sponsor

AbbVie — full company profile →

Who can join

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.

Response Ratio (RRatio) Primary · Baseline Period; Maintenance Phase Days 15 through 71

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.

Group	Value	95% CI
Placebo	-24.06	± 33.441
CVL-865 7.5 mg BID	-22.45	± 26.393
CVL-865 25 mg BID	-25.90	± 33.428
CVL-865 7.5 mg BID / 25 mg BID	-24.19	± 30.041

Percentage Change From Baseline in Focal Onset Seizure Frequency Per Week Over the Maintenance Phase Secondary · Baseline Period; Maintenance Phase Days 15 through 71

Seizure frequency is defined as the total number of focal onset seizures over the treatment period of interest divided by the total number of days with no missing seizure counts in the corresponding period multiplied by 7.

Group	Value	95% CI
Placebo	-26.2
CVL-865 7.5 mg BID	-27.2
CVL-865 25 mg BID	-29.8
CVL-865 7.5 mg BID / 25 mg BID	-28.5

Percentage of Participants With 50 Percent (%) Responder Rate Secondary · Baseline Period; Maintenance Phase Days 15 through 71

The 50% responder rate is defined as the percentage of participants with at least a 50% reduction in focal onset seizure frequency rate in the Maintenance Phase compared to the Baseline Period.

Group	Value	95% CI
Placebo	30.0
CVL-865 7.5 mg BID	34.8
CVL-865 25 mg BID	38.3
CVL-865 7.5 mg BID / 25 mg BID	36.6

Percentage of Seizure-free Participants During the Maintenance Phase Secondary · Maintenance Phase Days 15 through 71

Seizure freedom is defined as no seizures during the Maintenance Phase.

Group	Value	95% CI
Placebo	6.0
CVL-865 7.5 mg BID	2.2
CVL-865 25 mg BID	4.3
CVL-865 7.5 mg BID / 25 mg BID	3.2

Weekly Seizure Rate During the Maintenance Phase Secondary · Maintenance Phase Weeks 1, 2, 3, 4, 5, 6, 7, 8

Maintenance Phase Week 1

Group	Value	95% CI
Placebo	6.41	± 10.772
CVL-865 7.5 mg BID	5.20	± 5.867
CVL-865 25 mg BID	2.71	± 4.804
CVL-865 7.5 mg BID / 25 mg BID	3.95	± 5.472

Maintenance Phase Week 2

Group	Value	95% CI
Placebo	5.66	± 8.858
CVL-865 7.5 mg BID	4.98	± 5.982
CVL-865 25 mg BID	2.74	± 4.506
CVL-865 7.5 mg BID / 25 mg BID	3.84	± 5.370

Maintenance Phase Week 3

Group	Value	95% CI
Placebo	6.81	± 10.391
CVL-865 7.5 mg BID	6.53	± 9.010
CVL-865 25 mg BID	3.26	± 5.018
CVL-865 7.5 mg BID / 25 mg BID	4.88	± 7.414

Maintenance Phase Week 4

Group	Value	95% CI
Placebo	6.20	± 8.888
CVL-865 7.5 mg BID	6.44	± 9.974
CVL-865 25 mg BID	3.29	± 5.130
CVL-865 7.5 mg BID / 25 mg BID	4.87	± 8.044

Maintenance Phase Week 5

Group	Value	95% CI
Placebo	5.76	± 9.269
CVL-865 7.5 mg BID	6.27	± 8.688
CVL-865 25 mg BID	3.21	± 6.111
CVL-865 7.5 mg BID / 25 mg BID	4.75	± 7.639

Maintenance Phase Week 6

Group	Value	95% CI
Placebo	5.44	± 9.939
CVL-865 7.5 mg BID	6.21	± 8.313
CVL-865 25 mg BID	3.29	± 6.070
CVL-865 7.5 mg BID / 25 mg BID	4.79	± 7.408

Maintenance Phase Week 7

Group	Value	95% CI
Placebo	5.96	± 9.864
CVL-865 7.5 mg BID	6.40	± 8.520
CVL-865 25 mg BID	4.65	± 8.235
CVL-865 7.5 mg BID / 25 mg BID	5.56	± 8.381

Maintenance Phase Week 8

Group	Value	95% CI
Placebo	6.62	± 10.797
CVL-865 7.5 mg BID	5.23	± 6.883
CVL-865 25 mg BID	3.60	± 7.063
CVL-865 7.5 mg BID / 25 mg BID	4.45	± 6.975

Patient's Global Impression of Change (PGI-C) Score at Maintenance Phase Days 15, 43, and 71 Secondary · Maintenance Phase Days 15, 43, and 71

The self-report measure Patient's Global Impression of Change (PGI-C) reflects a participant's belief about the efficacy of treatment. It is a 7-point scale depicting a participant's rating of overall improvement where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. Lower scores indicate improvement.

Maintenance Phase Day 15

Group	Value	95% CI
Placebo	3.5	± 0.76
CVL-865 7.5 mg BID	3.3	± 0.96
CVL-865 25 mg BID	3.0	± 1.27
CVL-865 7.5 mg BID / 25 mg BID	3.1	± 1.13

Maintenance Phase Day 43

Group	Value	95% CI
Placebo	3.5	± 1.11
CVL-865 7.5 mg BID	3.2	± 1.06
CVL-865 25 mg BID	3.0	± 1.41
CVL-865 7.5 mg BID / 25 mg BID	3.1	± 1.24

Maintenance Phase Day 71

Group	Value	95% CI
Placebo	3.3	± 1.00
CVL-865 7.5 mg BID	3.0	± 1.02
CVL-865 25 mg BID	3.0	± 1.36
CVL-865 7.5 mg BID / 25 mg BID	3.0	± 1.19

Change From Baseline in Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score at Maintenance Phase Days 15, 43, and 71 Secondary · Baseline, Maintenance Phase Days 15, 43, and 71

The CGI-S is an observer-rated scale that was used to measure symptom severity. It is a 7-point scale depicting a participants rating of overall improvement. Participants rate their change as 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Negative changes from Baseline indicate improvement.

Maintenance Phase Day 15

Group	Value	95% CI
Placebo	-0.2	± 0.66
CVL-865 7.5 mg BID	0.0	± 0.94
CVL-865 25 mg BID	-0.3	± 0.87
CVL-865 7.5 mg BID / 25 mg BID	-0.2	± 0.92

Maintenance Phase Day 43

Group	Value	95% CI
Placebo	-0.2	± 0.97
CVL-865 7.5 mg BID	-0.2	± 1.05
CVL-865 25 mg BID	-0.6	± 0.91
CVL-865 7.5 mg BID / 25 mg BID	-0.4	± 1.00

Maintenance Phase Day 71

Group	Value	95% CI
Placebo	-0.3	± 0.97
CVL-865 7.5 mg BID	-0.3	± 1.09
CVL-865 25 mg BID	-0.7	± 1.09
CVL-865 7.5 mg BID / 25 mg BID	-0.5	± 1.10

Clinical Global Impression-Improvement Scale (CGI-I) Score at Maintenance Phase Days 15, 43, and 71 Secondary · Baseline, Maintenance Phase Days 15, 43, and 71

The CGI-I is an observer-rated scale that was used to measure the participant's symptom severity compared with before initiation of treatment with the investigational medicinal product (IMP). It is a 7-point scale depicting a participant's change from Baseline in symptom severity using the following response choices: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores indicate improvement.

Maintenance Phase Day 15

Group	Value	95% CI
Placebo	3.5	± 0.71
CVL-865 7.5 mg BID	3.4	± 0.83
CVL-865 25 mg BID	3.1	± 0.91
CVL-865 7.5 mg BID / 25 mg BID	3.2	± 0.88

Maintenance Phase Day 43

Group	Value	95% CI
Placebo	3.5	± 0.84
CVL-865 7.5 mg BID	3.3	± 1.02
CVL-865 25 mg BID	2.9	± 1.23
CVL-865 7.5 mg BID / 25 mg BID	3.1	± 1.15

Maintenance Phase Day 71

Group	Value	95% CI
Placebo	3.3	± 0.96
CVL-865 7.5 mg BID	3.3	± 0.98
CVL-865 25 mg BID	2.8	± 1.46
CVL-865 7.5 mg BID / 25 mg BID	3.0	± 1.25

Change From Baseline in Quality of Life in Epilepsy-31 (QOLIE-31) Overall Score at Maintenance Phase Day 71 Secondary · Baseline, Maintenance Phase Day 71

The Quality of Life in Epilepsy-31 (QOLIE-31) contains 7 multi-item scales that cover the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. A QOLIE-31 overall score is obtained using a weighted average of the multi-item scale scores. The QOLIE-31 also includes a single item that assessed overall health. The QOLIE-31 score range is from 0 to 100 with a higher score indicating a better outcome for quality of life. Positive changes from Baseline indicate improvement.

Group	Value	95% CI
Placebo	0.29	± 9.859
CVL-865 7.5 mg BID	2.08	± 12.717
CVL-865 25 mg BID	3.70	± 12.267
CVL-865 7.5 mg BID / 25 mg BID	2.91	± 12.445

Change From Baseline in Health Utilities Index (HUI) Utility Score at Maintenance Phase Day 71 Secondary · Baseline, Maintenance Phase Day 71

The Health Utilities Index (HUI) is a rating scale used to measure general health status and health-related quality of life. In HUI, utility values range from -0.03 and -0.36 for the HUI-2 and HUI-3, respectively, to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. Negative changes from Baseline indicate improvement.

HUI-2

Group	Value	95% CI
Placebo	-0.029	± 0.2579
CVL-865 7.5 mg BID	0.052	± 0.2162
CVL-865 25 mg BID	-0.014	± 0.3084
CVL-865 7.5 mg BID / 25 mg BID	0.018	± 0.2679

HUI-3

Group	Value	95% CI
Placebo	-0.025	± 0.3961
CVL-865 7.5 mg BID	0.110	± 0.3448
CVL-865 25 mg BID	-0.012	± 0.4469
CVL-865 7.5 mg BID / 25 mg BID	0.048	± 0.4027

Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Secondary · From first dose of study drug until 30 days following last dose of study drug (up to Day 120)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize

Any TEAE

Group	Value	95% CI
Placebo	28
CVL-865 7.5 mg BID	33
CVL-865 25 mg BID	46
CVL-865 7.5 mg BID / 25 mg BID	79

TESAE

Group	Value	95% CI
Placebo	1
CVL-865 7.5 mg BID	4
CVL-865 25 mg BID	1
CVL-865 7.5 mg BID / 25 mg BID	5

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) Secondary · Baseline; From first dose of study drug until 30 days following last dose of study drug (up to Day 120)

12-lead electrocardiogram (ECG) recordings were obtained after the participant had been supine and at rest for at least 5 minutes.

Absolute QTcF Interval (msec), > 450 and ≤480 msec

Group	Value	95% CI
Placebo	0
CVL-865 7.5 mg BID	1
CVL-865 25 mg BID	2
CVL-865 7.5 mg BID / 25 mg BID	3

Absolute QTcF Interval (msec), > 480 and ≤500 msec

Group	Value	95% CI
Placebo	0
CVL-865 7.5 mg BID	0
CVL-865 25 mg BID	0
CVL-865 7.5 mg BID / 25 mg BID	0

Absolute QTcF Interval (msec), > 500 msec

Group	Value	95% CI
Placebo	0
CVL-865 7.5 mg BID	0
CVL-865 25 mg BID	0
CVL-865 7.5 mg BID / 25 mg BID	0

Change from Baseline in QTcF Interval, > 30 - 60 msec

Group	Value	95% CI
Placebo	4
CVL-865 7.5 mg BID	2
CVL-865 25 mg BID	1
CVL-865 7.5 mg BID / 25 mg BID	3

Change from Baseline in QTcF Interval, > 60 msec

Group	Value	95% CI
Placebo	0
CVL-865 7.5 mg BID	0
CVL-865 25 mg BID	0
CVL-865 7.5 mg BID / 25 mg BID	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 127 days for the Placebo group,129 days for the CVL-865 7.5 mg BID group, and 127 days for the CVL-865 25 mg BID group.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/51 (2%)

Deaths: 0/51

CVL-865 7.5 mg BID

Serious: 4/51 (8%)

Deaths: 0/51

CVL-865 25 mg BID

Serious: 2/52 (4%)

Deaths: 0/52

Serious adverse events (7 terms)

Reaction	System	Placebo	CVL-865 7.5 mg BID	CVL-865 25 mg BID
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—
CHOLECYSTITIS	Hepatobiliary disorders	—	—	—
SKIN LACERATION	Injury, poisoning and procedural complications	—	—	—
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	—	—	—
MYOCLONUS	Nervous system disorders	—	—	—
SUICIDAL IDEATION	Psychiatric disorders	—	—	—
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	—	—	—

Other adverse events (27 terms — click to expand)

Reaction	System	Placebo	CVL-865 7.5 mg BID	CVL-865 25 mg BID
DIZZINESS	Nervous system disorders	—	—	—
SOMNOLENCE	Nervous system disorders	—	—	—
FATIGUE	General disorders	—	—	—
HEADACHE	Nervous system disorders	—	—	—
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—
FALL	Injury, poisoning and procedural complications	—	—	—
INSOMNIA	Psychiatric disorders	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—
BALANCE DISORDER	Nervous system disorders	—	—	—
ANXIETY	Psychiatric disorders	—	—	—
IRRITABILITY	Psychiatric disorders	—	—	—
VISION BLURRED	Eye disorders	—	—	—
DENTAL CARIES	Gastrointestinal disorders	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—
ASTHENIA	General disorders	—	—	—
COVID-19	Infections and infestations	—	—	—
HEAD INJURY	Injury, poisoning and procedural complications	—	—	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—	—	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—	—	—
WEIGHT INCREASED	Investigations	—	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—
DYSARTHRIA	Nervous system disorders	—	—	—
MEMORY IMPAIRMENT	Nervous system disorders	—	—	—
TREMOR	Nervous system disorders	—	—	—
APATHY	Psychiatric disorders	—	—	—
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: THROMBOCYTOPENIA, CHOLECYSTITIS, SKIN LACERATION, GENERALISED TONIC-CLONIC SEIZURE, MYOCLONUS, SUICIDAL IDEATION, PERIPHERAL ARTERY OCCLUSION.

Data from ClinicalTrials.gov NCT04244175 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development.
Perucca E, White HS, Bialer M. · · 2023 · cited 27× · PMID 37603261 · DOI 10.1007/s40263-023-01025-4
Established and emerging GABAA receptor pharmacotherapy for epilepsy.
Richardson RJ, Petrou S, Bryson A. · · 2024 · cited 24× · PMID 38449810 · DOI 10.3389/fphar.2024.1341472
Insights and progress on the biosynthesis, metabolism, and physiological functions of gamma-aminobutyric acid (GABA): a review.
Zhang Q, Zhu L, Li H, Chen Q, et al · · 2024 · cited 20× · PMID 39703920 · DOI 10.7717/peerj.18712
Epilepsy Characteristics in Neurodevelopmental Disorders: Research from Patient Cohorts and Animal Models Focusing on Autism Spectrum Disorder.
Chakraborty S, Parayil R, Mishra S, Nongthomba U, et al · · 2022 · cited 18× · PMID 36142719 · DOI 10.3390/ijms231810807
Pronounced antiseizure activity of the subtype-selective GABAA positive allosteric modulator darigabat in a mouse model of drug-resistant focal epilepsy.
Gurrell R, Iredale P, Evrard A, Duveau V, et al · · 2022 · cited 11× · PMID 35965432 · DOI 10.1111/cns.13927
Safety, Tolerability, and Pharmacokinetics of Multiple Repeated Oral Doses of the α2/3/5-Subtype Selective GABAA -Positive Allosteric Modulator PF-06372865 in Healthy Volunteers.
Gurrell R, Whitlock M, Wei H, Shen Z, et al · · 2021 · cited 5× · PMID 33465277 · DOI 10.1002/cpdd.912
Medicines for Anxiety: A Hundred Years of Tranquillity and More to Come?
Nutt D. · · 2026 · PMID 41717843 · DOI 10.1002/hup.70034

Verify or expand the search:

Other trials of CVL-865

Trials testing the same drug.

NCT04686786 — An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures · Phase 2 · terminated

Other recruiting trials for Seizures

Currently open trials in the same condition.

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NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04244175 (US National Library of Medicine, public domain)
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: 30 May 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/NCT04244175.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04244175

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (7 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of CVL-865

Other recruiting trials for Seizures

Other AbbVie trials

Verify against primary sources