I am currently enrolled in the Tcelna trial fpr SPMS ( Abili-T ). I have received two injectioms. Because it is double-blind, we don't know whether I am receiving the real stuff. I haven't noticed any improvement so far, although I know that is too early to tell. I am here thinking that there is no way I can last two years like this. I may have to start steroids again. There are no approved treatments for SPMS other than Novantrone which can be cardiotoxic.
I question the ethics of this double-blind study because of the following:
1). There are no approved treatments for SPMS other than Novantrone. Consequently even mild
improvements are welcomed
2). The product has no side effects. It is produced by your own body and a previous trial for
RRMS corroborated this finding ( TERMS trial ).
3). Even though the results failed to be statistically significant, the vast majority of patients
noticed improvements. The statistical findings could have been an artifact related to the
way patients were randomized.
4). An open-label trial with Tovaxin ( Tcelna's previous name ) was underway when funding
It is incomprehensible why (due to the reasons cited above), the FDA and / or Opexa went with a
double-blind study, instead of an open-label.
Last edited by xpsychiatricmd
on Wed Mar 13, 2013 5:47 pm, edited 1 time in total.