CVL-865 for Seizures

No longer recruiting at 84 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must be taking: Antiepileptic drugs

Must not be taking: P-gp, BCRP substrates

Disqualifiers: Generalized epilepsy, High-frequency seizures, others

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

Compensation: Varies

Number of Visits: 1

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CVL-865 to determine its effectiveness in reducing seizures in adults with epilepsy who have drug-resistant focal onset seizures. Participants will take CVL-865 alongside their usual anti-seizure medications to assess its impact on seizure frequency. The study also evaluates the safety of CVL-865. Individuals with epilepsy and focal onset seizures for more than two years, who continue to experience frequent seizures despite other medications, might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in epilepsy care.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should be on 1 to 3 permitted anti-epileptic drugs at a stable dose before starting. Some medications might be prohibited, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CVL-865 is safe and well-tolerated in previous studies. Participants using CVL-865 did not encounter major safety issues, indicating that most people respond well to the treatment. While minor side effects might occur, the data does not reveal any serious problems. This information suggests that CVL-865 could be a safe choice for those considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CVL-865 for treating seizures because it offers a fresh approach compared to traditional anticonvulsants like sodium valproate, carbamazepine, or lamotrigine. Unlike standard treatments that often work by stabilizing electrical activity in the brain, CVL-865 targets specific receptors in the brain called GABA-A receptors, potentially leading to fewer side effects. This unique mechanism could provide more effective seizure control with better tolerability, which is a significant advancement in managing epilepsy. Additionally, CVL-865's flexible dosing options allow for tailored treatment, possibly enhancing its effectiveness and patient experience.

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

Studies have shown that CVL-865 has promising seizure-preventing effects. In this trial, participants will receive either CVL-865 at different dosages or a placebo. Research indicates that, when combined with other anti-seizure medications, CVL-865 can reduce seizures in people with drug-resistant focal onset seizures. This treatment enhances the effects of a calming brain chemical called GABA. Initial findings suggest that CVL-865 can help decrease seizures for those who struggle with current medications. While evidence continues to grow, these early results show potential for managing hard-to-treat epilepsy. ^{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 adults with drug-resistant focal onset seizures, who've tried at least two anti-epileptic drugs without success and are currently on 1 to 3 stable AEDs. They must have had a minimum of eight seizures in the last eight weeks and been diagnosed with epilepsy for at least two years. Participants need a BMI between 17.5 to 40 kg/m^2 and weigh over 50 kg.

Inclusion Criteria

I agree to use a condom for 94 days after my last dose of the trial medication.

I have been diagnosed with focal epilepsy for at least 2 years.

I have tried at least 2 epilepsy drugs without success and am currently on 1 to 3 stable epilepsy drugs.

Exclusion Criteria

I am not currently using, nor likely to use, any medications not allowed by the study.

Your heart's electrical activity measured by ECG shows specific patterns that are too long.

I have trouble swallowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVL-865 or placebo tablets orally twice daily until Day 92

13 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CVL-865
• Placebo

Trial Overview The study tests CVL-865 as an additional treatment against placebo in people with focal onset seizures that don't respond well to other medications. The goal is to see if CVL-865 can reduce seizure frequency safely and tolerably.

How Is the Trial Designed?

Group I: CVL-865 7.5 mg BID Experimental Treatment 1 Intervention

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.

Group II: CVL-865 25 mg BID Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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.

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.