IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity (NT-Spin)

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Upper Limb Spasticity

Treatments: Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465738

MRZ 60201 - 0607 / 1

Details and patient eligibility

About

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

Full description

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Female or male patients ≥ 18 years
• Stable upper limb spasticity of diverse etiology
• Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
• Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits

Main Exclusion Criteria:

• Fixed contracture
• Bilateral upper limb paresis/paralysis
• Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
• Previous or planned treatment with phenol- or alcohol-injection in the target limb
• Other muscle hypertonia (e.g. rigidity)
• Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
• Severe atrophy of the target limb muscles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL

Experimental group

Description:

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL.

Treatment:

Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL

Active Comparator group

Description:

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.

Treatment:

Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")