The T-WAVE clinical study will evaluate whether investigational oral drug CX-8998 is safe for adolescents and adults diagnosed with idiopathic generalized epilepsy (IGE) with absence seizures and explore whether it is safe. Researchers will also explore if the drug is effective in decreasing the frequency and duration of seizures by reducing abnormal activity in certain regions of the brain.
Study participation, testing and medication are all free to participants. Some people may receive stipends to cover meals and travel related to study visits.
What is a clinical trial?
T-WAVE is a clinical trial -- a medical research study to explore whether an investigational intervention is safe and effective for humans. The purpose of conducting clinical trials is research, so the trials follow strict scientific standards. These standards protect patients and help produce reliable study results.
Patients with certain medical conditions, as well as healthy individuals, may volunteer to participate in clinical trials to help further medical knowledge and scientific progress.
A clinical trial may find that a new intervention improves patient outcomes, offers no benefit or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care. All new medications like CX-8998 are studied in clinical trials to generate data that can be evaluated by the US Food and Drug Administration (FDA) for safety and effectiveness before being approved for use in the United States.
The study is being conducted at several medical research centers in the United States. Participation may take up to nine weeks, including a four- week screening period, four-week treatment period and one week of follow-up. There will also be a follow up call about four weeks after your last dose to see how you are doing.
All participants eligible for T-WAVE will receive the investigational oral drug.
Eligibility requirements for the T-WAVE Study include:
- Men and women (not pregnant or breastfeeding) 16-55 years old
- Diagnosis of an idiopathic generalized epilepsy (IGE) such as childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy, or Jeavons syndrome with absence seizures
- On a stable dose of antiepileptic medication for at least 30 days, or documentation justifying lack of therapy
- Have no history of surgical intervention for the treatment of epilepsy
What does the study involve?
- Informed Consent – People who are eligible will be provided with a consent form to review carefully to ensure they fully understand the risks and benefits of participation.
- Screening Visit – Interested potential participants will start with a screening visit to confirm their epilepsy diagnosis and establish baseline information about their seizures and general health.
- Study Initiation – On the first day of the study, participants will take the first dose of the study medication and undergo testing.
- Study Assessments – Participants will take the study medication for 27 days with incremental increases in dosing and will have multiple phone calls and nurse home visits for assessments. Subjects will track their seizures in daily diaries.
- Study Completion – After 27 days on study medication, participants will cease taking the drug and have a nurse home visit for final evaluation in about a week.
About CX-8998
The brain’s neural network utilizes certain channels, called T-type calcium channels, that help control communication between brain regions. Idiopathic generalized epilepsy (IGE) with absence seizures is associated with abnormal activity of these signals. CX-8998 is an oral drug that was designed to selectively target T-type calcium channel activity in the brain’s neurons, acting as a biological ”pacemaker” to help restore the brain’s natural rhythms. Scientific data suggest that CX-8998 may reduce seizures by suppressing abnormal T-type calcium channel activity and restoring normal neural activity in relevant brain regions.
CX-8998 has been studied in nearly 250 people, mostly healthy volunteers and people with tremor and other neurological conditions. CX-8998 is being developed by Cavion, Inc., a patient-focused company advancing T-type calcium channel therapies for a range of neurological diseases.