I reached out to Biogen/IDEC regarding testing protocol, as I plan to be a participant, if accepted, and will need to travel.
Dan
Dear Dan.
Many thanks for your inquiry regarding dexpramipexole (KNS-760704) As it appears you are aware, a Phase 2 clinical study of this compound has been conducted with potentially promising results. On the basis of this data we are planning a Phase 3 clinical study (The EMPOWER Study), which will allow us to better understand the potential efficacy of this compound in ALS in a larger number of patients treated for a longer time. An important part of this study will also be to determine the safety of longer term dosing in ALS patients.
We anticipate the Phase 3 study will start in the April timeframe. This is an estimate however , the actual time at each location will depend on how long it takes the team there to get the necessary legal and regulatory approvals in place, which is to say the study could be starting at different time at different locations. As a policy Biogen Idec lists all of our clinical studies on Home - ClinicalTrials.gov . We would suggest that keeping abreast of the information on that web page would probably be the fastest and most accurate source of news about the study. Specific information about participating centers (locations and name) will be posted once those sites have the necessary approvals in place. In the meanwhile we have listed planned locations on the site.
Phase 3 Study of Dexpramipexole in ALS - Full Text View - ClinicalTrials.gov
Ultimately the individual doctors who are participating in the EMPOWER study would be responsible for and make the decision regarding the patients they enter into the study (that is, there is no application process directly to Biogen Idec, everything is based on the judgement of the doctors using medical criteria we have defined for the study). They can also discuss some of the specific questions you have about eligibility, travel etc.. Those who would be open to taking self referred patients wil provide a means to contact them on the website, once they have their approvals in place. Please keep posted there as information is updated in the coming months.
We understand the urgency you feel and share you hope that this and other drugs in testing for ALS will offer hope for ALS patients and their families. Please do not hesitate to contact us if you have further questions.
Kind Regards.
S Purdy
我我递交给Biogen公司关于测试协议，因为我打算成为一个参与者，如果接受，将需要前往。
担
亲爱的丹。
非常感谢您询问有关dexpramipexole（KNS-760704），因为它似乎你都知道，一二期临床研究这种化合物已进行与潜在可喜的成果。对这些数据的基础上，我们正计划第3期临床研究（EMPOWER的研究“），这将使我们更好地了解这种化合物在一个较长时间的治疗的患者数量较多的ALS的潜在功效。这项研究的一个重要组成部分，也将是决定延长ALS患者长期服药的安全。
我们预计将在4月的时间内开始第三阶段的研究。然而这是一个估计，在每个位置的实际时间将取决于需要多长时间队那里得到必要的法律和监管部门的批准，在地方，这是说的研究，可以在不同的地点在不同的时间开始。作为一项政策，Biogen Idec公司在首页列出我们所有的临床研究 - ClinicalTrials.gov。我们建议，该网页上的信息保持同步，很可能是最快和最准确的来源研究的新闻。一旦这些网站有必要的批准，将公布有关参与中心（地点名称）的具体信息。在此同时，我们在网站上列出了计划中的位置。
第3阶段研究在ALS Dexpramipexole - 全文查看 - ClinicalTrials.gov
最终的个别医生，谁是在参与使研究会负责，并作出决定，对他们将研究进入（即患者，有没有应用程序直接向Biogen Idec公司，一切都根据医生的判断使用的医疗条件，我们已经定义的研究）。他们还可以讨论你的资格，旅游等一些具体问题。这些人将是开放的，以自我简称患者WIL提供了一种手段，他们在网站上联系，一旦他们在他们的批准。请保持有信息，在未来几个月内更新发布。
我们了解你的感受和分享你希望和其他药物测试的ALS将提供ALS患者及其家属的希望的紧迫性。如果您有进一步问题，请不要犹豫与我们联系。
亲切的问候。
小号普尔蒂
狗仔卡
发表于 2012-2-22 23:42:56
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