Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Spasticity of the Upper and Lower Limb Due to Cerebral Causes

Treatments: Drug: IncobotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603459

MRZ60201_3053_1

2010-020886-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

Full description

A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.

Enrollment: 155 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Upper and lower limb spasticity of the same body side due to cerebral causes
• Time since event leading to spasticity in the target body side greater than 12 weeks
• Need for 800 units Botulinum toxin type A

Exclusion criteria

• Body weight below 50kg
• Fixed contractures of the target joint
• 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

IncobotulinumtoxinA (Xeomin) (up to 800 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