CVL-865 for Seizures

No longer recruiting at 63 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Status epilepticus, Noncompliance, Suicide risk, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 57 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new drug, CVL-865, for individuals with focal onset seizures. It aims to determine if CVL-865 can be safely used long-term alongside current treatments. Participants must have been involved in a previous related study and should not have experienced severe side effects or issues with the medication. The trial involves taking CVL-865 tablets twice daily for up to 57 weeks. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications, but it mentions that participants who are likely to need prohibited medications during the trial may be excluded. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that CVL-865 is likely to be safe for humans?

Research has shown that CVL-865 is safe and well-tolerated in previous studies. Participants experienced few side effects when using it alongside other treatments for seizures. Other studies have examined its safety and effectiveness, yielding promising results in controlling seizures when combined with other anti-seizure medications.

Since this trial is in Phase 2, the treatment has already passed initial safety tests. This phase focuses more on the treatment's effectiveness in a larger group. So far, evidence supports CVL-865 as a safe option for those with focal onset seizures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for seizures?

Unlike the standard seizure treatments, which often include medications like valproate or lamotrigine that stabilize electrical activity in the brain, CVL-865 is unique because it targets a specific type of receptor in the brain called GABA-A. This receptor is involved in calming nerve activity, and by selectively modulating it, CVL-865 aims to reduce seizures with potentially fewer side effects. Researchers are excited about CVL-865 because it offers a novel approach that could provide a better balance between effectiveness and tolerability for patients.

What evidence suggests that CVL-865 might be an effective treatment for seizures?

Research shows that CVL-865, the investigational treatment in this trial, may be a promising new option for seizures. Studies have found that it reduces the number of seizures when combined with other anti-seizure medications. Early results suggest that CVL-865 calms overactive brain signals that lead to seizures. In trials, patients taking CVL-865 experienced fewer seizures compared to those on a placebo. These findings indicate that CVL-865 could be effective for people with focal onset seizures. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for individuals who have focal onset seizures and completed treatment in a prior related trial (CVL-865-SZ-001). They must be able to follow the study plan, use effective contraception if of childbearing potential, and not have had severe reactions or poor tolerance to CVL-865 previously. Those with certain blood abnormalities, at risk of suicide, or needing prohibited medications can't join.

Inclusion Criteria

I understand the trial's requirements and believe I can follow them.

I agree to use effective birth control during and for 30 days after the trial.

I am able to understand and sign the consent form.

Exclusion Criteria

I won't need medications that aren't allowed in the trial.

You had a seizure 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVL-865 tablets orally twice daily up to a maximum dose of 25 mg until Week 57

57 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive CVL-865 as adjunctive therapy to assess long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• CVL-865

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called CVL-865 when used alongside other treatments for seizures. Participants will receive this medication over an extended period to monitor how well it works and any side effects that occur over time.

How Is the Trial Designed?

Group I: CVL-865 25 mg Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-865-SZ-001

A Trial of the Efficacy and Safety of CVL-865 as Adjunctive ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/a-trial-of-the-efficacy-and-safety-of-cvl-865-as-adjunctive-therapy-in-the-treatment-of-focal-onset

A Trial of the Efficacy and Safety of CVL-865 as Adjunctive ... 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 ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20486932

A Trial of the Effectiveness and Safety of CVL-865 to Treat ... The purpose of this study is to assess the effectiveness, safety, and tolerability profile of CVL-865 as adjunctive treatment in participants with drug- ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/75/NCT04244175/Prot_000.pdf

clinical protocol This proof-of-concept trial will assess whether CVL-865 demonstrates efficacy compared with placebo, as measured by a decrease in seizure frequency in subjects ...

5. news.abbvie.com news.abbvie.com/2019-04-09-Cerevel-Therapeutics-Announces-Publication-of-Phase-2a-Study-Results-in-Neurology-on-Its-Most-Advanced-Investigational-Epilepsy-Treatment

Cerevel Therapeutics Announces Publication of Phase 2a ... Findings Demonstrate Promising Anticonvulsant Activity with CVL-865, a Novel Selective GABA Potentiator, in Patients with Photosensitive ...

6. news.abbvie.com news.abbvie.com/2019-12-08-Cerevel-Therapeutics-Announces-Phase-1-Results-for-CVL-865,-a-Novel-2-3-5-subtype-GABAA-Positive-Allosteric-Modulator-in-Development-to-Treat-Epilepsy

Cerevel Therapeutics Announces Phase 1 Results for CVL ... CVL-865 is the first in a new class of treatments for epilepsy; Data presented at 2019 Annual Meeting of American Epilepsy Society.