Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122044
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-07-18
Brief Title:
Childhood Hypertonia of Central Origin A Trial of Anticholinergic Treatment Effects
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Childhood Hypertonia of Central Origin An Open Label Trial of Anticholinergic Treatment Effects
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label trial of trihexyphenidyl in children with upper extremity dystonia due to cerebral palsy It is hypothesized that trihexyphenidyl in doses up to 075mgkgday would be well-tolerated and show significant changes on the Melbourne scale of upper extremity function
Detailed Description:
BACKGROUND Although trihexyphenidyl has been used to treat both primary and secondary dystonia in children previous studies have not investigated efficacy in secondary dystonia We describe the results of a prospective open-label multi-center trial of high-dose trihexyphenidyl in children with secondary dystonia of the arms due to cerebral palsy
METHODS Twenty-six children age 4-15 years with cerebral palsy and dystonia that impairs function of the dominant upper extremity were enrolled All children were given trihexyphenidyl at increasing doses over 9 weeks up to 075mgkgday Trihexyphenidyl was subsequently tapered over 5 weeks Visits occurred at baseline 9 weeks and 15 weeks The primary outcome measure was the Melbourne assessment of upper extremity function tested in the dominant arm
RESULTS Three children withdrew due to non-serious adverse events chorea drug rash hyperactivity 3 children reduced dosage due to non-serious adverse events The 23 children who completed the study showed a significant improvement in arm function at 15 weeks p0045 but not at 9 weeks Post-hoc analysis showed that a subgroup N10 with hyperkinetic dystonia worsened at 9 weeks p004 but subsequently returned to baseline following taper of the medicine
CONCLUSIONS Trihexyphenidyl appears to be safe and effective for treatment of arm dystonia in children with cerebral palsy Children with hyperkinetic dystonia may worsen A larger randomized prospective trial is needed to confirm these results
METHODS Twenty-six children age 4-15 years with cerebral palsy and dystonia that impairs function of the dominant upper extremity were enrolled All children were given trihexyphenidyl at increasing doses over 9 weeks up to 075mgkgday Trihexyphenidyl was subsequently tapered over 5 weeks Visits occurred at baseline 9 weeks and 15 weeks The primary outcome measure was the Melbourne assessment of upper extremity function tested in the dominant arm
RESULTS Three children withdrew due to non-serious adverse events chorea drug rash hyperactivity 3 children reduced dosage due to non-serious adverse events The 23 children who completed the study showed a significant improvement in arm function at 15 weeks p0045 but not at 9 weeks Post-hoc analysis showed that a subgroup N10 with hyperkinetic dystonia worsened at 9 weeks p004 but subsequently returned to baseline following taper of the medicine
CONCLUSIONS Trihexyphenidyl appears to be safe and effective for treatment of arm dystonia in children with cerebral palsy Children with hyperkinetic dystonia may worsen A larger randomized prospective trial is needed to confirm these results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None