IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Blepharospasm

Treatments: Drug: incobotulinumtoxinA (Xeomin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406367

MRZ 60201-0433

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups, including a placebo group

incobotulinumtoxinA (Xeomin)

Experimental group

Description:

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") 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), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection

Treatment:

Drug: incobotulinumtoxinA (Xeomin)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo