Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke (PLUS)

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Post-stroke Spasticity of the Lower Limb

Treatments: Drug: IncobotulinumtoxinA (400 Units); Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464307

2010-024579-23 (EudraCT Number)

MRZ 60201/SP/3002

Details and patient eligibility

About

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Enrollment: 290 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18-80 yrs
• Lower limb spasticity
• Time since stroke greater than 3 months
• Need for 400 U Botulinum toxin type A

Exclusion criteria

• Body weight below 50kg
• Fixed contractures of the lower limb
• Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
• Infection at the injection site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups, including a placebo group

IncobotulinumtoxinA (Xeomin) 400 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.

Treatment:

Drug: IncobotulinumtoxinA (400 Units)

Placebo Comparator Arm

Placebo Comparator group

Description:

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Treatment:

Drug: Placebo Comparator