Bilateral Blepharospasm (BEB) Clinical Trial
Official title:
Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naïve Subjects With Blepharospasm
This phase 3 study will serve to collect efficacy and safety data of two different doses of
NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve.
In this study, BTX treatment-naïve subjects are defined as those who have not received BTX
treatment within the last 12 months for the treatment of BEB. This definition aims to avoid
bias by comparison of treatment effects in the subject's assessments. Furthermore, this study
will substantiate the existing efficacy and safety database for the indication BEB.
Subjects to receive one injection with NT 201 or placebo at baseline of the placebo-controlled first cycle. Thereafter, all subjects entering the Open-Label Extension Period (OLEX) to receive a second injection of NT 201 (second injection cycle). ;