Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Post-stroke Spasticity of the Upper Limb.
Intervention
IncobotulinumtoxinA (400 Units), Placebo Comparator
Location
Merz Investigational Site #001184
Downey
California
United States
90242
Status
Active, not recruiting
Source
Merz Pharmaceuticals GmbH
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01392300
- Information obtained from ClinicalTrials.gov on May 21, 2013
Medical and Biotech [MESH] Definitions
Muscle Spasticity
A form of muscle hypertonia associated with upper MOTOR NEURON DISEASE. Resistance to passive stretch of a spastic muscle results in minimal initial resistance (a "free interval") followed by an incremental increase in muscle tone. Tone increases in proportion to the velocity of stretch. Spasticity is usually accompanied by HYPERREFLEXIA and variable degrees of MUSCLE WEAKNESS. (From Adams et al., Principles of Neurology, 6th ed, p54)
Movement Disorders
Syndromes which feature DYSKINESIAS as a cardinal manifestation of the disease process. Included in this category are degenerative, hereditary, post-infectious, medication-induced, post-inflammatory, and post-traumatic conditions.
Cerebral Palsy
A heterogeneous group of nonprogressive motor disorders caused by chronic brain injuries that originate in the prenatal period, perinatal period, or first few years of life. The four major subtypes are spastic, athetoid, ataxic, and mixed cerebral palsy, with spastic forms being the most common. The motor disorder may range from difficulties with fine motor control to severe spasticity (see MUSCLE SPASTICITY) in all limbs. Spastic diplegia (Little disease) is the most common subtype, and is characterized by spasticity that is more prominent in the legs than in the arms. Pathologically, this condition may be associated with LEUKOMALACIA, PERIVENTRICULAR. (From Dev Med Child Neurol 1998 Aug;40(8):520-7)
Stroke
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Clinical Trials
Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors us...
Effects on Quality of Life Following Dysport Treatment in Post-Stroke Spasticity of the Arm
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasti...
Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth...
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined appli...
PubMed Articles
Primary objective: To determine the extent to which the Brunnstrom recovery stages of upper limb in hemiparetic stroke patients are correlated to neurophysiological measures and the spasticity measure...
Occurence and Clinical Predictors of Spasticity After Ischemic Stroke.
BACKGROUND AND PURPOSE: There is currently no consensus on (1) the percentage of patients who develop spasticity after ischemic stroke, (2) the relation between spasticity and initial clinical finding...
Background: In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb...
Upper limb spasticity affecting elbow, wrist, and finger flexors can be safely and effectively reduced with injections of botulinum toxin type-A (BoNT-A). It has been best studied in adults in the con...
Intrafusal effects of botulinum toxin injections for spasticity: Revisiting a previous paper.
Botulinum toxin, frequently used to manage focal limb spasticity, has been reported to affect both extrafusal and intrafusal fibers of the injected muscle. Since most studies have used spinal reflexes...
