Status:
COMPLETED
Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
United Cerebral Palsy Foundation
Don and Linda Carter Foundation
Conditions:
Dystonia
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
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 0.75mg/kg/day would be well...
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 resu...
Eligibility Criteria
Inclusion
- Dystonia in the dominant upper extremity
Exclusion
- Complete absence of voluntary movement in the affected hands, wrists, and elbows
- Severe weakness in the dominant upper extremity (MRC grade \< 4)
- Passive range of motion at the hand, wrist or elbow less than 80% of normal
- Current use of medications for dystonia (anticholinergics, L-dopa, baclofen, diazepam, tizanidine, tetrabenazine, reserpine, and others)
- Changes in the subject's physical therapy regimen for the duration of the 15-week study
- Prior use of trihexyphenidyl or other anticholinergic therapy for dystonia.
- History of surgery on the dominant upper extremity or cervical spine
- Botulinum toxin injection in the dominant upper extremity within the previous 6 months
- Current or prior implantation of an intrathecal baclofen pump, deep brain stimulator, or other device to treat dystonia or spasticity
- Concurrent acute or chronic medical condition (such as frequent seizures, heart disease, or asthma) that could adversely affect motor performance or the safety of testing
- Presence of diurnal fluctuations or other clinical signs and symptoms suggesting an inborn error of metabolism, a family history of dystonia suggesting a genetic dystonia, or dystonia due to injury after the neonatal period (including toxin exposure, trauma, or medication-induced)
- History of allergic or adverse reaction to trihexyphenidyl or other anticholinergic medications
- Current complaint of urinary retention requiring treatment.
- History of glaucoma, or family history of glaucoma with onset before age 40
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00122044
Start Date
January 1 2003
End Date
December 1 2004
Last Update
May 23 2014
Active Locations (7)
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1
University of Alabama School of Medicine
Birmingham, Alabama, United States, 35233
2
Stanford University
Stanford, California, United States, 94305-5235
3
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
4
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205