Prilenia Therapeutics recently announced the enrollment of the first participant in Europe for its phase 3 clinical trial in Huntington disease patients.

The PROOF-HD trial is a pivotal trial being conducted in North America and Europe in collaboration with the Huntington Study Group. The first U.S. subjects were enrolled in October 2020. The purpose of the PROOF-HD study is to evaluate the efficacy and safety of pridopidine in patients with early stage Huntington disease. The primary endpoint is Total Functional Capacity. The treatment period will last up to 78 weeks and there will be an optional open-label extension.

Huntington disease is an inherited, neurodegenerative disorder that usually begins to be symptomatic starting at around 40 years of age. Persons with Huntington disease suffer from a progressive movement disorder, cognitive decline, psychiatric disturbances, and behavioral symptoms. All symptoms progress which eventually leads to immobility, dementia, and premature death.

Below, Michael Hayden, PhD, Chief Executive Officer of Prilenia Therapeutics, talks about the PROOF-HD trial and its primary outcome measure.

 

 

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