Sadly nearly 72 patients that were taking TYSABRI or the STANDARD OF CARE for their SPMS could be worse off then some Haitians as the medical personnel on Federal payrolls (or others?) may be ignoring their pleas for continuation of TYSABRI therapy....
While this clinical trial was scheduled to end after 32 weeks....the FDA & NIH owe these humans (NOT guinea pigs!) an answer....on whether or not their TYSABRI therapy will be continued.
A total of 72 patients with SPMS were enrolled in this clinical trial. There were three patients on one form of TYSABRI therapy for every single patient on the present STANDARD OF CARE.
13 received TYSABRI in it's present Intravenous (IV) form 13 received TYSABRI in an injected form intramuscularly, a needle into muscle (IM) 13 received TYSABRI in a subcutaneous method (SC), a needle just below the skin 13 received the present STANDARD OF CARE therapy for SPMS
The last update on this clinical trial was done June 15, 2009 which essentially changed the recruiting status to show that the trial was filled & no longer recruiting patients.
The duration of the pharmcokinetics and pharmcodynamics of this study was to last simply 32 weeks. The 32 weeks would have ended sometime before January 26, 2010. Knowing that the FDA is slow to put update the clinical trial website and knowing that TYSABRI therapy must be given every 28 days means some of these humans may be suffering!
The responsible party or the FDA owe an answer as to whether TYSABRI therapy should be continued. These are human beings & US citizens (NOT guinea pigs and certainly NOT Haitians).
History of NCT00559702
Brief title: Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Record State: RELEASED Updated View Type of info changed 2007_11_15 Study Nothing (earliest version on record) 2007_12_11 Study Changes Recruitment, Administrative, Misc. 2007_12_12 Study Changes Misc. 2008_01_04 Study Changes Recruitment, Misc. 2008_08_31 Study Changes Recruitment, Location/Contact, Misc. 2009_01_29 Study Changes Recruitment status, Recruitment, Misc. 2009_06_15 Study Changes Recruitment, Misc.