VIDEO: Phase 3 trial of essential tremor treatment features at-home participation
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DENVER — A phase 3 trial of ulixacaltamide for essential tremor will involve at-home patient participation and a clinical endpoint of activities of daily living, according to a speaker at the American Academy of Neurology annual meeting.
Rich Able, PhD, vice president of global medical affairs at Praxis Precision Medicines, said in this Healio video that the ESSENTIAL3 study will allow patients to participate entirely from home.
A registered nurse will go to patients’ homes to provide medications and safety assessments, he said.
“They will also have their own investigator who will remote into the home to do the actual clinical assessments,” Able said. “These patients will never have to go into a clinical site.”
Additionally, he said Praxis worked with the FDA to ensure that modified activities of daily living was a clinical endpoint of the study.
“It’s an endpoint that’s also relevant to the patient,” Able said.