Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
Condition: Bilateral Blepharospasm (BEB)
MeSH terms: Blepharospasm
Intervention: IncobulinumtoxinA (Xeomin), 25 Units; IncobotulinumtoxinA (Xeomin), 12.5 Units; Placebo; IncobotulinumtoxinA (Xeomin), 35 Units
Intervention description: IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 25 Units per eye.; IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 12.5 Units per eye.; Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Open-Label Extension: up to 35 Units per eye.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female out-patients age ≥ 18 and ≤ 80 years.

          -  A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic,
             intermittent or persistent involuntary contractions of orbicular oculi muscles.

          -  A need for injection of BTX defined as a Jankovic Rating Scale [JRS] severity subscore
             ≥ 2.

          -  Treatment-naïve subject defined as at least 12 months without BTX of any serotype for
             the treatment of BEB before administration of IP.

        Exclusion Criteria:

          -  Subject with any previous unsuccessful treatment with BTX of any serotype for the
             treatment of BEB.

          -  Atypical variant of BEB (e.g., apraxia of the eyelid opening) caused by inhibition of
             levator palpebrae muscle.

          -  Neuroleptic-induced blepharospasm.

          -  Myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation,
             spinal cord stimulation) and surgery in the upper face.

          -  Generalized disorders of muscles activity (e.g., myasthenia gravis in particular
             ocularis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any other
             significant neuromuscular dysfunction which might interfere with the study.