2023年6月1日

NeuroMetrix鼓勵二期平息NeuroMetrix試驗數據報告數據,以便其無線設備經皮電神經刺激對化療所致周圍神經病變。NeuroMetrix報道積極的試驗數據對其無線設備經皮電神經刺激對化療所致周圍神經病變。NeuroMetrix正準備禮物平息部分試驗結果,該公司的無線經皮電神經刺激(十)設備,治療化療引起的周圍神經病變在美國臨床腫瘤學會(ASCO)在芝加哥。美國國立衛生研究院(NIH)資助,多站點、假對照、主題和評估員盲隨機試驗(NCT04367480)進行結合NCI社區腫瘤學研究項目(NCORP)來評估設備的功效。推薦報告CIPN共有142名參與者被隨機一個活躍的或虛假的壓製設備6周。受試者在兩個手臂被要求穿裝置每天5個小時。受試者接受刺激在1小時治療會議之後1小時休息時間。安慰劑平息是相同的,除了它交付隻有2.5分鍾的刺激在治療期。中度到重度患者CIPN熱/灼痛的症狀,夏普/射擊疼痛或肌肉痙攣有經驗對積極治療症狀減少50%相比,約30%為虛假的治療。初步療效證據表明數萬承諾從CIPN疼痛和痙攣,但不太可能改善感到麻木和刺痛。 The results are consistent with a previous open-label study by NeuroMetrix. “Quell offers the potential for a safe and effective treatment that can be administered at home,” said Neurometrix CEO Shai N. Gozani. “We look forward to obtaining further details on the trial results over the coming months and will correspondingly finalise our regulatory strategy, potentially to include a near term regulatory submission for a Quell CIPN indication. We are also enthusiastic about continuing to support Dr. Gewandter and her colleagues at NCORP as they pursue a confirmatory trial that further investigates the clinical benefits of Quell in CIPN.” In January 2022, Quell received a breakthrough device designation for chronic CIPN by the US Food and Drug Administration (FDA). Quell had previously received FDA authorisation for fibromyalgia and is currently marketed as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Share this article