Status:
COMPLETED
"DOES MYOBLOC™ IMPROVE FUNCTIONAL HAND USE IN YOUNG CHILDREN WITH A HYPERTONIC UPPER EXTREMITY?"
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Cerebral Palsy
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Subjects: 10 subjects age 2-17 years with hypertonia affecting one or both upper extremities, but without injections of neuromuscular blocking agents for six months prior to enrollment, or surgery on ...
Eligibility Criteria
Inclusion
- 1\. Age 2- 17 years 2. Hypertonia affecting one or both upper extremities 3. Hypertonia caused by static encephalopathy due to prenatal or perinatal injury 4. Cognitive and motor function sufficient so that the child will reliably reach toward a target or a small toy 5. Concurrent enrollment in "standard of care" physical therapy or occupational therapy services
Exclusion
- 1\. Injection of neuromuscular blocking agents to any extremity within six months prior to enrollment 2. Dose changes of trihexyphenidyl, dantrolene, baclofen, dopaminergic agents or benzodiazepines during the course of the study.
- 3\. Any use of aminoglycoside antibiotics during the study. 4. Prior surgery to either upper extremity 5. Initiation or change in physical or occupational therapy regimen within 3 months of study entry 6. Progressive or neurodegenerative disease, or suspicion of an inborn error of metabolism 7. Neuropathy, myopathy, or neuromuscular junction disease 8. Congenital deformities of either upper extremity 9. Respiratory or airway compromise, or use of respiratory medications 10. Cardiomyopathy 11. Any other medical condition that would place the child at risk for participation
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00238641
Start Date
January 1 2002
End Date
May 1 2005
Last Update
October 13 2005
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305-5235