IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Condition: Blepharospasm
MeSH terms: Blepharospasm
Intervention: incobotulinumtoxinA (Xeomin); Placebo
Intervention description: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection; Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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