"DOES MYOBLOC™ IMPROVE FUNCTIONAL HAND USE IN YOUNG CHILDREN WITH A HYPERTONIC UPPER EXTREMITY?"
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
Summary
In children with cerebral palsy, stiffness of the arm can develop early and delay or prevent
the acquisition of normal hand skills. Improvement in functional use of the hand may
therefore be dependent upon early treatment of upper extremity hypertonia. We propose to test
a series of injections of Myobloc™ in a non-randomized one-way crossover pilot clinical trial
and dose-finding study, with clinical assessments and blinded video evaluations. Ten children
age 2-17 years with increased tone at the elbow or wrist will be expected to complete the
study. A 1-month baseline evaluation period will be followed by an injection of low-dose
Myobloc™ to affected muscle(s) of the arm according to standardized per-kilogram dosing with
a maximum of 25U/kg in each affected arm. Three months later, a second injection of up to
50U/kg will be performed in each affected arm. Three months after the second dose, a third
dose of up to 100U/kg will be performed in each affected arm. Neurological assessments will
be performed at study entry, prior to each injection, and at 1 and 3 months following each
injection. Routine physical therapy and non-study medications will be continued during the
study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Stanford University
Collaborator:
Elan Pharmaceuticals
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA rimabotulinumtoxinB