SeizuresPhase 2NCT04686786
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
A Phase 2 study testing CVL-865 in people with Seizures, run by AbbVie at 56 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seizures
- What is being tested?
- CVL-865
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 56 sitesin 7 countries
- Study dates
- 8 Dec 2020to 5 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who completed treatment in Trial CVL-865-SZ-001 (NCT04244175)
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent through 30 days post last dose
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with the investigational medicinal product (IMP)
- Participants who are capable of giving signed informed consent
- Participants who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures
Who cannot join
- Participants who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial
- Participants who, in the judgment of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the participant may not be appropriate for 57 weeks of treatment with CVL-865 in an extension trial
- Participants who experienced status epilepticus during Trial CVL-865-SZ-001
- Participants who have demonstrated substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial
- Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent), or participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), or participants who, in the opinion of the investigator, present a serious risk of suicide
- Participants with any of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary (Females: Hemoglobin <11 gram per deciliter (g/dL); Males: hemoglobin <12 g/dL; White blood cell (WBC) count <3.0 x 10 power 9 per liter (10^9/L); Neutrophil count <2.0 x 10^9/L; Platelet count <150 × 10^9/L)
- Participants who would be likely to require the use of prohibited concomitant medications during the trial
- Female participants who have a positive pregnancy test result
Trial locations and contacts
56 sites in 7 countries.
56 sites in 7 countries
United States26 sites
Baltimore, Maryland
Baltimore, Maryland, 21287
Bethesda, Maryland
Bethesda, Maryland, 20817
Boston, Massachusetts
Boston, Massachusetts, 02114
Charleston, South Carolina
Charleston, South Carolina, 29425
Chesterfield, Missouri
Chesterfield, Missouri, 63005
Gulf Breeze, Florida
Gulf Breeze, Florida, 32561-4458
Hackensack, New Jersey
Hackensack, New Jersey, 07601
Honolulu, Hawaii
Honolulu, Hawaii, 96817
Jacksonville, Florida
Jacksonville, Florida, 32224
Lexington, Kentucky
Lexington, Kentucky, 40504
Little Rock, Arkansas
Little Rock, Arkansas, 72205
Miami Lakes, Florida
Miami Lakes, Florida, 33016
Nashville, Tennessee
Nashville, Tennessee, 37232
New Haven, Connecticut
New Haven, Connecticut, 06519
New York
New York, New York, 10021
Oklahoma City, Oklahoma
Oklahoma City, Oklahoma, 73112
Orlando, Florida
Orlando, Florida, 32806
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania, 19104
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania, 19107
Port Charlotte, Florida
Port Charlotte, Florida, 33952
Rochester, New York
Rochester, New York, 14642
Salt Lake City, Utah
Salt Lake City, Utah, 84132
Scarborough, Maine
Scarborough, Maine, 04074
Saint Louis, Missouri
St Louis, Missouri, 63110
Tampa, Florida
Tampa, Florida, 33606
Toledo, Ohio
Toledo, Ohio, 43614
Australia8 sites
Camperdown, New South Wales
Camperdown, New South Wales, 2050
Fitzroy, Victoria
Fitzroy, Victoria, 3065
Heidelberg, Victoria
Heidelberg, Victoria, 3084
Herston, Queensland
Herston, Queensland, 4029
Melbourne, Victoria
Melbourne, Victoria, 3004
Parkville, Victoria
Parkville, Victoria, 3050
Randwick, New South Wales
Randwick, New South Wales, 2031
Westmead, New South Wales
Westmead, New South Wales, 2145
Spain8 sites
Barcelona, Catalunya
Barcelona, Catalonia, 08003
Barcelona, Catalonia
Barcelona, Catalonia, 08035
Madrid
Madrid, 28034
Madrid
Madrid, 28040
Malaga,
Málaga, Andalusia, 29010
Sevilla
Seville, 41013
Terrassa, Catalonia
Terrassa, Catalonia, 08222
Valencia
Valencia, 46026
Poland7 sites
Białystok
Bialystok, 15-704
Bydgoszcz, Kujawsko-Pomorskie
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163
Gdańsk, Pomorskie
Gdansk, Pomeranian Voivodeship, 80-803
Kraków, Malopolskie
Krakow, Lesser Poland Voivodeship, 31-209
Lodz
Lodz, Łódź Voivodeship, 90-752
Warszawa
Warsaw, 02-952
Wojnicz, Lskie
Wojnicz, Wojnicz Lskie, 40-650
Ukraine3 sites
Kyiv
Kyiv, 02091
Lviv
Lviv, 79035
Uzhgorod
Uzhhorod, Uzhgorod, 88018
Serbia2 sites
Kragujevac, Sumadija
Kragujevac, Sumadija, 34000
Neurology Department, Kragujevac
Kragujevac, Sumadija, 34000
South Korea2 sites
Gwangjin-gu, Seoul
Gwangju, Seoul, 05030
Irwon-Ro Gangnam-gu., Seoul
Irwon-dong, Seoul, 06351
About this study
Official title: A 57-Week, Multicenter, Active-treatment, Open-label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
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.
- Conditions
- Seizures
- Being tested
- CVL-865
- Keywords
- CVL-865, Anti-epileptic drugs (AEDs), PF-06372865, γ-aminobutyric acid (GABA), focal epilepsy, partial seizure
- Medical subject headings
- Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-865Drug
Also called PF-06372865
Participants will receive 25 mg CVL-865 tablets orally BID during the treatment period. The dose may be decreased to 17.5 mg BID for tolerability.
| Study group | Role | What they receive |
|---|---|---|
| CVL-865 25 mg | Experimental | Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Week 57 during the treatment period. Receives: Drug: CVL-865 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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 required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in the 'Reported Adverse Events module'.
Measured: From first dose of study drug up to Week 61
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)
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)'.
Measured: Baseline up to Week 57
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Measurements
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.
Measured: Baseline up to Week 57
Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination Results
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 changes in physical or neurological examination results.
Measured: Baseline up to Week 57
Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)
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).
Measured: Baseline up to Week 61
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)
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.
Measured: Week 57, Week 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start8 Dec 2020
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Why it stopped: Closed early after CVL-865-SZ-001 (NCT04244175) did not meet its primary objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686786
- Sponsor's protocol ID
- CVL-865-SZ-002
- Other IDs
- 2019-004057-83, 2019
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2020
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurrell R, Iredale P, Evrard A, Duveau V, Ruggiero C, Roucard C. Pronounced antiseizure activity of the subtype-selective GABAA positive allosteric modulator darigabat in a mouse model of drug-resistant focal epilepsy. CNS Neurosci Ther. 2022 Nov;28(11):1875-1882. doi: 10.1111/cns.13927. Epub 2022 Aug 14.
PubMed 35965432
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 57-Week, Multicenter, Active-treatment, Open-label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
- ClinicalTrials.gov ID
- NCT04686786
- Acronym / sponsor ID
- CVL-865-SZ-002
- Conditions
- Seizures
- Keywords
- CVL-865, Anti-epileptic drugs (AEDs), PF-06372865, γ-aminobutyric acid (GABA), focal epilepsy, partial seizure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early after CVL-865-SZ-001 (NCT04244175) did not meet its primary objective
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVL-865 25 mg | Experimental | Drug: CVL-865Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Week 57 during the treatment period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who completed treatment in Trial CVL-865-SZ-001 (NCT04244175)
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent through 30 days post last dose
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with the investigational medicinal product (IMP)
- Participants who are capable of giving signed informed consent
- Participants who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures
Key exclusion criteria (8 listed)
- Participants who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial
- Participants who, in the judgment of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the participant may not be appropriate for 57 weeks of treatment with CVL-865 in an extension trial
- Participants who experienced status epilepticus during Trial CVL-865-SZ-001
- Participants who have demonstrated substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial
- Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent), or participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), or participants who, in the opinion of the investigator, present a serious risk of suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL-865Also: PF-06372865Participants will receive 25 mg CVL-865 tablets orally BID during the treatment period. The dose may be decreased to 17.5 mg BID for tolerability. | Drug | CVL-865 25 mg |
Primary outcome
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: 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 required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in the 'Reported Adverse Events module'.
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)
Time frame: 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)'.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Measurements
Time frame: 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.
Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination Results
Time frame: 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 changes in physical or neurological examination results.
Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)
Time frame: 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).
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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35965432Gurrell R, Iredale P, Evrard A, Duveau V, Ruggiero C, Roucard C. Pronounced antiseizure activity of the subtype-selective GABAA positive allosteric modulator darigabat in a mouse model of drug-resistant focal epilepsy. CNS Neurosci Ther. 2022 Nov;28(11):1875-1882. doi: 10.1111/cns.13927. Epub 2022 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
56 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVL-865 in people with Seizures, run by AbbVie at 56 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Australia, Spain, Poland, Ukraine and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: From first dose of study drug up to Week 61). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.