IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Blepharospasm

Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.

Main Inclusion Criteria:

• Male or female pretreated outpatients between ages 18 and 80 years (inclusive)
• A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
• A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore >= 2)
• 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
• Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry
• At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline

Main Exclusion Criteria:

• Atypical variant of BEB caused by inhibition of levator palpebrae muscle
• Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
• The previous two injections with BOTOX® with more than 50 Units per eye
• Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
• Neuroleptic induced blepharospasm
• Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
• Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to Baseline and during the trial