IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cervical Dystonia

Treatments: Drug: incobotulinumtoxinA (Xeomin) (120 Units); Drug: Placebo; Drug: incobotulinumtoxinA (Xeomin) (240 Units)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407030

MRZ 60201-0408

Details and patient eligibility

About

At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Enrollment: 233 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Male or female outpatients between ages 18 and 75 years inclusive)
• A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score)
• TWSTRS-Total score >= 20
• TWSTRS-Severity score >= 10
• TWSTRS-Disability score >= 3
• TWSTRS-Pain score >= 1
• On a stable dose of 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
• For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry
• For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline
• For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B

Main Exclusion Criteria:

• Traumatic torticollis or tardive torticollis
• TWSTRS-Severity score for anterocollis >= 2 points (pure anterocollis)
• TWSTRS-Severity score for retrocollis >= 2 points (pure retrocollis)
• Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
• Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A
• Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
• Current swallowing disorder of any origin (dysphagia scale >= 3, i.e. severe, with swallowing difficulties and requiring a change in diet)
• Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome
• Treatment with Botulinum Toxins for any indication other than cervical dystonia 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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233 participants in 3 patient groups, including a placebo group

incobotulinumtoxinA (Xeomin) (240 Units)

Experimental group

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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection

Treatment:

Drug: incobotulinumtoxinA (Xeomin) (240 Units)

incobotulinumtoxinA (Xeomin) (120 Units)

Experimental group

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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection

Treatment:

Drug: incobotulinumtoxinA (Xeomin) (120 Units)

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% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection

Treatment:

Drug: Placebo