The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Cala Trio for the treatment of action tremors in the hands of adults with Parkinson’s disease, Cala Health Inc reports in a news release.
Cala Trio is currently FDA-cleared to relieve hand tremors from essential tremor (ET). The Company expects to initiate the next clinical trials evaluating the therapy in the treatment of action hand tremors in patients with Parkinson’s disease by the end of 2020.
“While hand tremor in patients living with Parkinson’s disease typically occurs when the arm is at rest while sitting or walking, it is also estimated that more than half of patients also experience action tremor, which occurs when the arm is being used to perform an activity or task.
“Furthermore, published data suggest that levodopa, the primary treatment for motor symptoms of Parkinson’s disease, is not usually effective in treating this type of tremor, which can negatively affect performing daily tasks like eating and writing. For this reason, treatment for action tremor in patients with Parkinson’s disease remains a significant unmet medical need that impacts their daily activities and overall quality of life.”
— Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida
Cala Trio, a non-invasive targeted therapy, is currently available in the US by prescription. Cala Health sought Breakthrough Device Designation for Cala Trio because many patients with Parkinson’s disease experience the same action tremor as patients with essential tremor.
The Company expects to initiate the next clinical trials of Cala Trio virtually in patients with Parkinson’s disease in 2020. Virtual clinical trials will allow participants to volunteer from home, using the therapy as indicated in the study design and having telemedicine visits with a neurologist throughout the study.
“Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies. We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy.”
— Kate Rosenbluth, PhD, Founder and Chief Scientific Officer of Cala Health
[Source(s): Cala Health Inc, Business Wire]
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