Cavion is committed to pioneering new treatments by testing our technology in compassionately innovative clinical trials that use subject-friendly methods of data collection. We are currently recruiting people with essential tremor for a multi-center clinical trial.
The T-CALM study will evaluate whether investigational oral drug CX-8998 reduces the severity of tremors by reducing abnormal activity in certain regions of the brain. The study will also assess side effects of the drug, measure its impact on quality of life and further examine how the drug works.
The study is being conducted with more than 90 participants, 18-75 years of age at multiple medical research centers in the United States. People with essential tremor will participate in the study for 5 weeks. Participants in the study will be randomly assigned to one of two groups – half will receive the study drug and the other half will be given a placebo (sugar pill). In order to scientifically assess the effects of the drug, neither the participants nor the clinical team will know during the study what group each participant is in.
You may be eligible for the study even if you are already taking one medication for tremor. (However, people using Primidone will be asked to discontinue it prior to starting the study.) Other eligibility criteria will be reviewed with the study clinical team before proceeding with enrollment.
The brain’s neural network has calcium channels, called Cav3, that help control the firing and signaling between neurons. Some neurological disease, such as essential tremor, are associated with abnormal activity of these signals. CX-8998 is an oral drug that was designed to selectively modulate these calcium channels between in the brain’s neurons, acting as a biological ‘pacemaker’ to help regulate neural activity and reduce tremor.
CX-8998 has been studied in nearly 200 people, mostly healthy volunteers, and some people with other neurological conditions.
The safety and efficacy of CX-8998 for treatment of essential tremor have not been established.