Prospective, double-blind, placebo-controlled, randomized, multi-center trial with a double-blind parallel-group extension period to investigate the efficacy and safety of different doses of NT 201 in the treatment of cervical dystonia

The purpose of this research study is to evaluate the safety and effectiveness of a newly developed investigational formulation of botulinum neurotoxin, NT 201, compared with placebo (an inactive substance) in subjects with cervical dystonia. About 222 subjects in the United States will participate in the study. This study consists of two parts: the first part called the main period followed by the second part, the extension period. Study treatment in the main period will last for a minimum of eight weeks and up to a maximum of 20 weeks, and will consist of at least four visits, one telephone contact and optional visits and/or telephone contacts.Participation in the extension period will last for a maximum of 68 weeks, and will consist of up to 11 visits and five telephone contacts.

You may be eligible to participate in this study if you:

• Are a male or female outpatient between the ages of 18 and 75 years (inclusive)
• A clinical diagnosis of cervical dystonia, i.e., spasmodic torticollis, with predominantly rotational form
• Exhibit a need for treatment as assessed by rating scale that will be performed by study doctor
• Are on a stable dose of other medications (if any) used for focal dystonia treatment (e.g., anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the main period

You will be excluded from this study if you:

• Have traumatic torticollis or tardive torticollis
• Have pure antrocollis or pure retrocollis
• Had prior surgery of the neck muscles
• Have a known sensitivity to the study drug or its components

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.