154 Participants Needed

CVL-865 for Seizures

Recruiting at 73 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AbbVie
Must be taking: Antiepileptic drugs
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called CVL-865 for people whose seizures are not controlled by current treatments. The medication works by balancing brain activity to help reduce seizures. CVL-865 is one of the newer antiepileptic drugs with a novel mode of action compared to more established treatments.

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.

Who Is on the Research Team?

AI

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.
See 5 more

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.
See 13 more

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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CVL-865 7.5 mg BIDExperimental Treatment1 Intervention
Group II: CVL-865 25 mg BIDExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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 profile image

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+
Unbiased ResultsWe believe in providing patients with all the options.
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