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

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Post-stroke Spasticity of the Upper Limb

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392300

2010-023043-15 (EudraCT Number)

MRZ 60201/SP/3001

Details and patient eligibility

About

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Full description

The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Enrollment: 317 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Upper 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 upper 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: Double Blind

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317 participants in 2 patient groups, including a placebo group

DB IncobotulinumtoxinA (Xeomin) (400 U)

Experimental group

Description:

IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Treatment:

Drug: IncobotulinumtoxinA (400 Units)

DB Placebo Comparator

Placebo Comparator group

Description:

Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Treatment:

Drug: Placebo Comparator