This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of this research study is to evaluate the safety and effectiveness of a newly developed investigational formulation of Botulinum Neurotoxin, NT 201, a highly purified form of Botulinum Neurotoxin as compared with placebo (an inactive substance) in subjects with cervical dystonia. Cervical dystonia symptoms are caused by involuntary activity of the muscles of the neck which may lead to permanent spasm in the regions affected. Two Botulinum Toxins are currently approved by the FDA under the brand names Botox (Botulinum Toxin type A) and Myobloc (Botulinum Toxin type B) for the treatment of cervical dystonia. Unfortunately, after a time, between 3% and 10% of subjects treated no longer respond to the commercially available products containing Botulinum Toxin. It is suspected that the fairly large quantities of other ingredients (complex proteins) also present in these products may cause the body's defenses to react. As a result, the active substance becomes inactive by the formation of antibodies (proteins created by the body in response to a foreign substance). Allergic reactions may also occur. For these reasons, a special manufacturing process has been used to develop a new investigational drug containing only traces of the accompanying proteins that are thought to inactivate the neurotoxin or cause resistance to develop.
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