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Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of single-dose MYOBLOC over a 1-year duration in adult subjects with lower limb spasticity, followed by an open-label extension safety study of multiple doses.
Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of a single-dose of MYOBLOC over a 1-year duration in adult subjects with lower limb monoplegia or hemiplegia spasticity due to stroke or TBI, followed by an open-label extension safety study of multiple doses. The primary goal is to assess efficacy of MYOBLOC versus placebo in the treatment of adult lower limb spasticity. The secondary goals are: to establish a safe and efficacious dose of MYOBLOC (administered intramuscularly as a single total dose, to assess the duration of therapeutic response of MYOBLOC after a single administration, and to evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations at 13-week intervals over a minimum duration of 1 year.
Not yet recruiting
US WorldMeds LLC
Published on BioPortfolio: 2019-09-26T05:42:29-0400
To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spa...
The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.
The purpose of this study is t to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
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/uncontrollab...
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.
The purpose of this review is to familiarize the reader with assessments and measurement of spasticity in people with multiple sclerosis (MS). Spasticity affects 60-84% of people with MS, worsening as...
Spasticity commonly occurs in hemiplegic patients with stroke, and clinical experience indicates that upper limb spasticity is more apparent when patients are standing than when they are lying down. F...
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). The neural mechanisms contributing to its development are not yet understood. Using neurophysiological...
Spasticity and pain frequently co-occur in persons with spinal cord injury (SCI), yet, how these sequelae interact in daily life is unclear. Additionally, little is known about how psychological facto...
Evidence exists that placebo effects may influence hormone secretion. However, only few studies examined placebo effects in the endocrine system, including oxytocin placebo effects. We studied whether...
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)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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)
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1211)
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