Blepharospasm Short Interval

Prospective, Open-label, Single-arm, Single-center Trial to Investigate the Tolerability of NT 201 and Quality of Life of Patients in the Treatment of Blepharospasm With Shortened Injection Intervals

The objective of this Phase II study is to show that pre-treated patients with BEB with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated NT 201 injections at short injection intervals. In addition, the tolerability of repeated shortened NT 201 administrations in patients with BEB including the development of neutralizing antibodies will be investigated.

Inclusion Criteria:

• A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
• Medical need for treatment with shortened injection intervals (< 12 weeks) confirmed by the patient and investigator
• Blepharospasm Disability Index (BSDI) at baseline visit before injection of > / = 1,6

Exclusion Criteria:

• Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid)
• Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
• The previous three injections with Botulinum toxin Type A with more than 50 Units [U] per eye per injection session
• Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to baseline and during the trial