US-based biotechnology firm Cavion has started patient enrolment in a Phase II clinical trial (T-CALM Study) of CX-8998 to treat essential tremor (ET).
CX-8998 is an oral calcium channel modulator being developed to selectively regulate T-type channels called Cav3 that control firing and signalling between neurons.
The T-type calcium channel modulator is intended to restore natural rhythms of the brain.
Designed to enrol 92 patients at 18 medical research centres in the country, the Phase II trial will evaluate the efficacy of CX-8998 to decrease tremors and improve quality of life.
The multi-centre, randomised, double-blind, placebo-controlled, parallel-group trial will assess subjects through standard clinical trial scales and digital markers to objectively quantify tremor.
Cavion chief medical officer and research and development executive vice-president Spyros Papapetropoulos said: “We believe that Cavion’s new therapy may significantly improve the quality of life of people with essential tremor, offering hope to them and their families.”
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The trial’s primary outcome measure is change in tremor from baseline to day 28 on the essential tremor rating assessment scale (TETRAS) Performance.
Expected to be completed next year, the trial will assess increasing doses of CX-8998 and involve videotaping of patients in order to minimise rater bias during TETRAS assessment.
The firm plans to conduct an additional sub-study with electrophysiological measures to investigate the effect of CX-8998 on neuronal networks.
The sub-study will utilise an electroencephalography (EEG) and magnetoencephalography (MEG) to record power-spectral brain activity in certain neuro-anatomical locations.