Treatment of blepharospasm

The purpose of this research study is to evaluate the safety and effectiveness of a newly developed investigational formulation of botulinum neurotoxin, NT 201, as compared with placebo (an inactive substance) in subjects with blepharospasm. A total of 112 subjects will participate in this study across 24 study center in the United States. The study consists of two phases. Participation in the main period will last for a minimum of seven weeks and up to a maximum of 21 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 69 weeks, and will consist of up to 11 visits and, if required, additional optional visits. Total participation is expected to last approximately 27 months.

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

• Are 18 to 75 years old (inclusive)
• Have previously been treated
• Have been diagnosed with bilateral blepharospasm characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
• Have a need for injection
• Are on a stable dose of other medications (if any) used for the treatment of focal dystonia for at least 3 months prior to and expected throughout the main period of the study

You will be excluded from this study if you:

• Have an atypical type of blepharospasm
• Have had prior surgery in the affected muscles
• Have had previous two treatments with outside study limits
• Have a known sensitivity to the study material or its constituents

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.