GENERATION HD2 Trial Amended, NeuroOne Completes Submission for OneRF Ablation System, FDA Authorizes Implantable Continuous EEG Monitoring System

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to a community letter by Roche, the company has amended its phase 3 GENERATION HD2 trial (NCT05686551) to include only a higher dose of tominersen, after interim data revealed this dosage may be more likely to show benefit in patients with Huntington disease (HD). The independent data monitoring committee (iDMC), those who helped make the decision, did not find any safety concerns with the agent, and the trial remains on track to conclude in 2026. GENERATION HD2, a trial that began in 2022, comprised of 301 patients with HD testing 2 dose levels of tominersen (100 mg and 60 mg) against placebo, administered every 4 months via a spinal injection. In a pre-planned interim analysis, the iDMC concluded that the study should continue on, with the 100 mg dose more likely to result in clinical benefit. Based on this decision, only the 100 mg dose will be tested, and the 60 mg dose will be discontinued.

According to a recent announcement, NeuroOne formally completed its FDA submission for its proprietary OneRF Ablation System for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the U.S. The OneRF Trigeminal Nerve Ablation system offers a minimally invasive approach that uses radiofrequency (RF) energy to target and destroy abnormal tissue, providing relief from severe, chronic facial pain. Its multi-contact probe enables precise pain localization, stimulation, and ablation–using a single electrode–with the added safety of temperature-controlled lesioning.

According to a new announcement, the FDA has granted De Novo authorization to Epiminder’s Minder, an implantable continuous electroencephalogram monitoring system (iCEM), marking it as the first device of its kind approved in the United States for patients with epilepsy. The device is expected to formally launch in the second half of 2025 through a phased rollout at leading epilepsy centers as part of the company’s strategy to demonstrate the system’s clinical utility. The decision was supported by data from the UMPIRE study, a multi-center, prospective, open-design, case-controlled trial conducted in Australian hospitals between 2019 and 2023. According to the company, Minder successfully captured high-quality EEG data over extended periods, including a continuous 5-year recording in 1 participant.

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