Encora Therapeutics has announced the successful completion of the ULTRE (Upper Limb Tremor Reduction in Essential Tremor) clinical trial. This study assessed the safety, tolerability, and effectiveness of Encora’s wrist-worn stimulation device for patients with essential tremor (ET), a condition that affects the upper limbs of approximately 7.6 million people in the United States. Existing treatments for ET are often ineffective and poorly tolerated, highlighting the urgent need for new options.

The ULTRE trial involved 47 patients and followed a rigorous design. It was a double-blind, randomised, sham-controlled, cross-over clinical study. Two types of vibrotactile stimulation—Pulsed and Continuous—were compared against a placebo device. Participants had to meet strict criteria, ensuring the study’s reliability and clinical relevance.

The primary focus of the trial was on safety and tolerability, while secondary objectives included changes in motor function and the ability to perform daily tasks.

The impact of the device was measured using established clinical scales, including the Essential Tremor Rating Assessment Scale (TETRAS) and the Bain & Findley Activities of Daily Living (BF-ADL) scale. Tremor severity was assessed by experienced, blinded video raters and through patient self-assessment.

The results of the ULTRE study have provided valuable insights into the device’s potential, showing it to be both safe and well tolerated. The study’s progress reflects a clear demand for new therapeutic options for people with Essential Tremor, offering hope for those affected by this challenging condition.

Encora Therapeutics is now preparing to share the results of the study in a forthcoming publication.

 

 

Source: businesswire.com

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