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An Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Followed by an Open-Label Multiple-Treatment Safety Study

2019-09-26 05:42:29 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Spasticity

Intervention

rimabotulinumtoxinB, Placebo

Status

Not yet recruiting

Source

US WorldMeds LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-26T05:42:29-0400

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Medical and Biotech [MESH] Definitions

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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