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.
Randomized controlled study of the T-type calcium channel antagonist MK-8998 for the treatment of acute psychosis in patients with schizophrenia.
Hum Psychopharmacol. 2013 Mar;28(2):124-33. doi: 10.1002/hup.2289.
If you have patients that may be candidates for TCALM, or would like to receive more information about the study, please complete the form below. You can also refer patient candidates to our study sites for more information.