T-CALM may be a worthwhile option for your patients suffering from debilitating tremors who meet the study criteria and are not satisfied with currently available treatment options.

T-CALM (clinicaltrials.gov) will evaluate whether the investigational oral drug CX-8998 decreases the severity of tremors by reducing abnormal activity in certain regions of the brain. The study will utilize a combination of the Essential Tremor Rating Assessment Scale (TETRAS) and accelerometry as well as state-of-the-art digital biomarkers to objectively assess tremor. The study will also assess side effects of CX-8998, measure its impact on quality of life and further examine the drug’s mechanism of action.  

This double-blind, placebo-controlled phase 2 parallel study is being conducted with more than 90 participants at multiple medical research centers in the United States. Randomized participants will enter a four-week double-blind dose titration treatment period followed by a one-week safety follow-up.

CX-8998 is an oral drug being developed by Cavion that was designed to restore the brain’s natural rhythms by modulating overactive T-type calcium channels.

Calcium and ion channels play a critical role in neuronal signaling.  The T-type calcium channel Cav 3 mediates the transition from tonic to bust-firing and generates neural “oscillations” between brain nuclei and across neural networks. Cav 3 mediates the transition to burst-firing and abnormal oscillatory patterns in a number of neurologic disorders, including essential tremor, Parkinson’s disease, dystonia, epilepsy, pain, and schizophrenia. CX-8998 is a potential best-in-class Cav3 modulator with superior potency and selectivity as well as a favorable safety and tolerability profile.

CX-8998 has been studied in nearly 200 people, mostly healthy volunteers and some people with other neurological conditions.