Clinical Trials for Epilepsy
Clinical trials are health-related studies that research or investigate medical strategies, treatments, or devices to see if they are safe and effective for people who have diseases or disorders such as epilepsy. A clinical trial may test an intervention such as:
- A medical product, like a drug or device.
- A medical procedure.
- Instructions on how to change behavior, such as how to change your diet.
The Clinical Trials Portal connects participants to current trials and observational studies to help accelerate the development and testing of new treatments.
Who performs clinical trials?
Each clinical trial is led by a principal investigator, often a medical doctor. The trial will also have a research team that may include doctors, nurses, social workers, and other healthcare professionals. Clinical trials take place in many locations including hospitals, medical research centers, medical offices, and community clinics. The location depends on who is conducting the trial.
How do clinical trials work?
Investigators create a plan for the clinical trial, called a protocol. The investigators share the protocol with volunteers so they can make decisions about whether or not they want to participate. This information might include
- Who will conduct the research.
- Who is eligible to participate.
- What will be researched and why.
- When the research will be scheduled and for how long.
- How the results will be reported.
Why are clinical trials important?
Investigators use clinical trials to try to find out whether an intervention will be helpful, harmful, or no different than other interventions.
Clinical trials can be used to
- Identify or diagnose a particular disease or condition.
- Prevent the initial development or reappearance of a disease or condition.
- Treat a disease or condition.
- Identify risk factors for a disease or condition.
- Improve comfort and quality of life.
Source: https://www.cdc.gov/epilepsy/managing-epilepsy/clinical_trials.htm
Current Clinical Trials
Realize Study
Apply: https://realizestudy.com/
What is it?
A Phase 2 study evaluating an investigational medication called CVL-865 as a treatment for adults with focal onset (partial) seizures.
Who is eligible?
- Be 18 to 75 years old
- Be diagnosed with epilepsy with focal onset seizures for at least 2 years
- Have tried at least 2 other epilepsy treatments that did not work to control your seizures
- Not currently take one of the following medications every day: XCopri, Aptiom, Tegretol, Carbatrol, Dilantin, Klonopin, Onfi, Luminal
This is not a complete list of study requirements, and the study doctor will review the full requirements for the study with the participants.
There will be no charge to study participants for their participation in this study. The study drug, study-related procedures, and study visits will be provided at no charge.
Why is this study being conducted?
In this study, doctors want to find out if the investigational medication CVL-865 is effective in decreasing the frequency of seizures (how often they occur) without causing too many side effects. Some participants in this study will receive CVL-865, while others will receive a placebo. Placebo is a substance that looks like an investigational drug but does not contain an active drug. Researchers will compare the groups (those taking CVL-865 and those taking placebo to see if there is a difference in the number of seizures during the research study compared to before the research study.
What will happen in this study?
If you are eligible and consent to participate in this study, you will be randomly assigned (like drawing straws) to receive either CVL-865 (at one of 2 different doses) or a placebo. You will take the study drug as tablets by mouth twice a day. Neither you nor your study doctor will know which treatment you are receiving.
This trial is designed with a maximum duration of approximately 25 weeks. All participants who complete the trial will have the opportunity to participate in a long-term safety study in which all participants will receive CVL-865.