CAMBRIDGE, Mass.--(BUSINESS WIRE)--Encora Therapeutics is pleased to announce the successful completion of the ULTRE (Upper Limb Tremor Reduction in Essential Tremor) clinical trial. This study evaluated the safety, tolerability, and efficacy of Encora's wrist-worn stimulation device for patients with essential tremor (ET), a tremor disorder affecting the upper limbs of an estimated 7.6 million Americans. Current treatment options for ET are often inadequate and poorly tolerated, underscoring the critical need for new therapeutic approaches.
The 47-patient ULTRE study was designed as a double-blind, randomized, sham-controlled, cross-over clinical trial, adhering to rigorous scientific standards. Two distinct vibrotactile stimulation paradigms—Pulsed and Continuous—were compared with an inactive sham control. Participants were required to meet stringent inclusion criteria, ensuring the study’s robustness and clinical relevance.
The trial’s primary endpoints focused on safety and tolerability, while secondary endpoints evaluated changes in motor function and daily task performance, offering a thorough assessment of the device’s impact.
Patients were assessed using relevant portions of validated clinical scales, including the Essential Tremor Rating Assessment Scale (TETRAS) and the Bain & Findley Activities of Daily Living (BF-ADL) scale. Tremor severity was evaluated by blinded, experienced video raters and through blinded patient self-assessment, providing comprehensive and objective data throughout the study.
“The ULTRE study design is exceptionally rigorous and uniquely suited for a therapeutic study of Essential Tremor,” said Dr. Rodger Elble, study investigator and research consultant.
“Enrollment in the Encora ULTRE study progressed rapidly, demonstrating a strong interest and unmet need for novel therapeutic modalities among people with Essential Tremor. The Encora device showed excellent safety and tolerability to date, increasing confidence and bringing this pioneering innovation a step closer while providing new hope to patients,” said Dr. Fatta B. Nahab, Principal Investigator of the study.
“The completion of the ULTRE trial with encouraging results is a significant milestone in our journey to develop innovative, non-invasive solutions for this underserved patient population,” said Daniel Carballo, CEO at Encora Therapeutics. “Results will be detailed in an upcoming publication.”
For more information about Encora Therapeutics or to register to participate in future trials, please visit: encoratherapeutics.com
About Encora Therapeutics
Encora Therapeutics is a leading innovator in wearable neuromodulation technology, dedicated to developing non-invasive solutions to improve the lives of individuals with movement disorders, such as Essential Tremor.
