皮質刺激治療中風的EVEREST研究未能降低主要試驗終點率


  January 24, 2008 — Northstar Neuroscience公司已經發布EVERST研究,這是該公司對中風倖存者使用皮質刺激做為復健以外的輔助治療,但未能降低主要試驗終點。
  
  這項研究的主要療效終點為開始復健治療四週後手與上臂的功能,以肢體Fugl-Meyer檢測(UEFM)與以手臂運動能力檢測(AMAT)評估的日常生活能力。
  
  在四週的後續追蹤,Northstar Neuroscience公司在新聞稿中表示,30.8%接受皮質刺激的病患達到臨床上有意義改善閥值的綜合試驗終點,相較於控制組的29.1%。主要試驗終點之間必須有20%的絕對差距才能達到主要試驗終點。
  
  EVERST研究:四週的主要試驗終點分析

試驗終點

刺激組, n (%)

控制組, n (%)

差距(%)

P ( 單邊 )

UEFM > 4.5 分且 AMAT > 0.21 分

28 (30.8)

16 (29.1)

1.7

0.41


  主要試驗終點的次組分析發現組間並無統計上顯著差異。
  
  Northstar Neuroscience公司總裁與CEO的John Bowers在公司的聲明中表示,EVERST研究並未確認之前可行性試驗所觀察到,皮質刺激治療中風可以改善運動功能的效果;我們顯然地對這項研究無法達到主要試驗終點感到失望。
  
  該聲明中附帶提到,該公司目前正在收集並處理進行到24週時的長期研究數據;我們的數據分析尚未完成,根據初期的研究數據回顧,本公司並不相信目前的分析結果,一旦分析完成,將會有足夠的證據支持提交給食品藥物管理局的上市前申請案。
  
  Bower先生附帶表示,該公司受到這項治療可靠的安全性數據激勵,並計畫繼續使用該專利Renova皮質刺激系統來研究皮質刺激治療在別的適應症上的療效,包括憂鬱症與耳鳴;他在聲明中表示,在接下來幾個星期,我們將要提供更多有關我們未來計畫的詳細內容。
  
  這項研究由Northstar Neuroscience公司贊助。

EVEREST Trial of Cortical Stim

By Susan Jeffrey
Medscape Medical News

January 24, 2008 — Northstar Neuroscience has announced that the EVEREST trial, its pivotal study using cortical stimulation as an adjunct to rehabilitation therapy in stroke survivors, failed to meet its primary end point.

The primary efficacy end point was a composite, assessing gains in hand and arm function 4 weeks after the conclusion of rehabilitation therapy as measured by the Upper Extremity Fugl-Meyer test (UEFM) and the ability to perform activities of daily living as measured by the Arm Motor Ability Test (AMAT).

At the 4-week follow-up, a press release from Northstar Neuroscience notes, 30.8% of patients receiving cortical stimulation achieved the threshold of clinically meaningful improvement on the composite primary end point, vs 29.1% of controls. An absolute difference of 20% between groups was required to meet the primary end point.

EVEREST Trial: 4-Week Primary Efficacy Analysis
End Point
Stimulation, n (%)
Control, n (%)
Difference (%)
P (1-sided)
Composite gains of UEFM > 4.5 points and AMAT > 0.21 points
28 (30.8)
16 (29.1)
1.7
0.41

Secondary analysis of the components of the primary end point did not show any statistical difference between groups.

"The EVEREST study did not confirm the positive results of cortical stimulation therapy for stroke motor recovery observed in prior feasibility studies," John Bowers, president and CEO of Northstar Neuroscience, said in the company statement. "We are obviously very disappointed that the study missed its primary efficacy end point."

The company is currently collecting and processing longer-term data through 24 weeks, the statement adds. "While our analysis of the data is not complete, based on preliminary review, the company does not believe that this analysis, once completed, will demonstrate sufficient evidence of efficacy to support a premarket approval submission to the [Food and Drug Administration]."

Mr. Bowers added that the company was encouraged by the "strong safety profile" of the therapy and plans to continue investigation of cortical stimulation using its proprietary Renova Cortical Stimulation System in other indications, including depression and tinnitus. "In the coming weeks, we intend to provide more detail about our plans going forward," he said in the statement.

The study was funded by Northstar Neuroscience Inc.

    
相關報導
暫時性腦缺血發作的專門單位與極低的事件比率有關
2016/5/6 上午 09:47:01
中風發生率與空氣品質不佳有關
2016/3/2 下午 06:32:37
偏頭痛會增加抽菸者的中風風險
2015/8/13 下午 04:06:04

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁