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CVL-865 for Seizures

Phase 2
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a diagnosis of epilepsy with focal onset, as defined in the International League Against Epilepsy (ILAE) Classification of Seizures, focal aware, focal impaired awareness, and focal to bilateral tonic-clonic seizures for at least 2 years prior to signing the Informed Consent Form (ICF)
Participants must have a body mass index (BMI) of 17.5 to 40.0 kilogram per meter square (kg/m^2) and a total body weight greater than (>) 50 kilograms (kg) [110 pounds (lbs)]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, day 43, day 71, day 92 and/or early termination (et)
Awards & highlights

Study Summary

This trial will test if CVL-865 is an effective, safe, and tolerable treatment for people with drug-resistant focal onset seizures.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of CVL-865 aren't listed, common ones for seizure medications include dizziness, fatigue, nausea, mood changes, or skin rashes. Safety will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with focal epilepsy for at least 2 years.
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My BMI is between 17.5 and 40, and I weigh more than 110 lbs.
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I've had 4 or more seizures a month for the last 3 months.
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My brain scans showed no worsening abnormalities when my epilepsy was diagnosed.
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I've had at least 8 seizures in the last 8 weeks without a 3-week break.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15, day 43, day 71, day 92 and/or early termination (et)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15, day 43, day 71, day 92 and/or early termination (et) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response Ratio (RRatio)
Secondary outcome measures
Change From Baseline in Clinical Global Impression-Improvement Scale (CGI-I) Score at Day 15, 43 and 71
Change From Baseline in Focal Onset Seizure Frequency per Week over the Maintenance Phase
Change from Baseline in Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score at Day 15, 43 and 71
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose: CVL-865 7.5 mgExperimental Treatment1 Intervention
Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg until Day 92 during the treatment period.
Group II: High Dose: CVL-865 25 mgExperimental Treatment1 Intervention
Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Day 92 during the treatment period.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo matched to CVL-865 tablets orally BID until Day 92 during the treatment period.

Find a Location

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,565 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures
Eliza Hueda, MDStudy DirectorCerevel Therapeutics, LLC
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
450 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures

Media Library

CVL-865 Clinical Trial Eligibility Overview. Trial Name: NCT04244175 — Phase 2
Seizures Research Study Groups: Placebo, High Dose: CVL-865 25 mg, Low Dose: CVL-865 7.5 mg
Seizures Clinical Trial 2023: CVL-865 Highlights & Side Effects. Trial Name: NCT04244175 — Phase 2
CVL-865 2023 Treatment Timeline for Medical Study. Trial Name: NCT04244175 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved CVL-865 for general usage?

"Although clinical data exists to endorse the safety of CVL-865, no evidence has been collected in support of its efficacy. Therefore, this drug was given a score of 2 on our scale from 1 to 3."

Answered by AI

In what areas is the clinical trial being implemented?

"Patients for this research experiment are being gathered from Aurora, Colorado; Spokane, Washington; Los Angeles, California; and an additional 36 sites."

Answered by AI

What criteria must individuals meet to qualify for this research initiative?

"This trial is seeking 150 individuals with seizures, aged between 18 and 75. Participants must meet additional eligibility criteria such as having a minimum of 4 observed focal onset seizures in the past 28 days over 3 months (84 days) pre-screening, 8 focal onset seizures across an 8 week baseline period without any 21 day periods free from these seizure types, have tried and failed at least two previous antiepileptic drugs currently taking 1 to 3 permitted AEDs for four weeks prior to screening visit, BMI ranging from 17.5 kg/m^2 to 40.0kg/m^2 and body weight greater than 50 kilograms"

Answered by AI

How many people are enrolled in the current experiment?

"In order to properly conduct the trial, 150 individuals who meet all of the inclusion criteria need to enroll. Individuals can partake in this research at distinct sites like Aurora, Colorado and Spokane, Washington."

Answered by AI

Does the eligibility criteria for this trial encompass individuals aged 55 or older?

"This clinical trial is eligible for patients aged 18 to 75 years. There are 39 trials specifically targeting minors and 63 studies aimed at elderly individuals."

Answered by AI

Are there any opportunities to participate in this research endeavor at present?

"Correct. Clinicaltrials.gov attests that this medical trial, originated on January 27th 2020, is actively looking for participants to join its ranks. 150 people are being recruited from 36 various sites around the world."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
2020. "A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04244175.
~29 spots leftby May 2025
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