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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Female participants who have a positive pregnancy test result
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 54 up to week 61
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the long-term effects of a new seizure medication.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions due to long-term use of CVL-865 as part of their seizure treatment regimen.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 54 up to week 61
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 54 up to week 61
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
+3 moreSide effects data
From 2015 Phase 2 trial • 302 Patients • NCT022627544%
Nausea
4%
Nasopharyngitis
3%
Fall
3%
Back pain
3%
Rash
3%
Sinusitis
3%
Constipation
1%
Eye haemorrhage
1%
Cataract
1%
Arthralgia
1%
Muscle spasms
1%
Headache
1%
Nasal congestion
1%
Pneumonia
1%
Tooth infection
1%
Upper respiratory tract infection
1%
Tooth fracture
1%
Electrocardiogram abnormal
1%
Pain in extremity
1%
Insomnia
1%
Restlessness
1%
Cough
1%
Paranasal sinus discomfort
1%
Chest pain
1%
Rhinitis allergic
1%
Sinus congestion
1%
Rosacea
1%
Ileus paralytic
1%
Dyspnoea
1%
Fatigue
1%
Bronchitis
1%
Gastroenteritis
1%
Somnolence
1%
Abnormal dreams
1%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen
Placebo
PF-06372865
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 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 Week 57 during the treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CVL-865
2020
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
36 Previous Clinical Trials
5,394 Total Patients Enrolled
1 Trials studying Seizures
154 Patients Enrolled for Seizures
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
475 Total Patients Enrolled
1 Trials studying Seizures
154 Patients Enrolled for Seizures
Eliza HuedaStudy DirectorCerevel Therapeutics, LLC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the trial's requirements and believe I can follow them.I won't need medications that aren't allowed in the trial.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.You had a seizure during Trial CVL-865-SZ-001.You have already participated in the trial CVL-865-SZ-001 (NCT04244175).I am pregnant.I agree to use a condom during treatment and for 94 days after the last dose if my partner could become pregnant.Your blood test results show low levels of hemoglobin, white blood cells, neutrophils, or platelets.If you have had thoughts about hurting yourself or have made plans to hurt yourself, or if the doctor thinks you may be at serious risk of hurting yourself.I had a bad reaction or new safety concerns to the trial medication previously.
Research Study Groups:
This trial has the following groups:- Group 1: CVL-865 25 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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